Teamleader Productie

  • Location: Londerzeel
  • Type: Perm
  • Job #13371

Teamleader Productie

Vast Contract – Regio Londerzeel
#voeding #productie #people management

Beschik je over een bachelor en werkervaring met people management in een productieomgeving? Sta je communicatief sterk in de schoenen en heb je menselijk inzicht? Lees dan vooral verder.

Onze partner is op zoek naar een Teamleader Productie om hun productieteam te leiden. Dit toonaangevend productiebedrijf gelegen in de regio Londerzeel is internationaal actief binnen de voedingsindustrie en staat bekend omwille van hun aandacht voor kwaliteit, innovatie en familiariteit.

Jouw verantwoordelijkheden?

Als Teamleader Productie kom je terecht in een dynamische omgeving en krijg je de verantwoordelijkheid over het aansturen van een team bestaande uit een tiental operatoren. Jouw takenpakket bestaat uit een aantal diverse activiteiten:

  • Opstellen van de werkverdeling en productieplanning
  • Opvolgen van productie- en procesparameters
  • Het team coachen, motiveren en ondersteunen
  • Meewerken aan het kwaliteitssysteem en veiligheidsplan
  • Samenwerken met de technische dienst om apparatuursproblemen op te lossen
  • Waken over de veiligheid, kwaliteit en rentabiliteit van de productieprocessen
  • Direct rapporteren aan de Operations Manager

Wie ben je?

Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Teamleader Productie idealiter over een voedingsgerelateerde bachelor aangevuld met een eerste leidinggevende ervaring. Ervaring binnen een voedingsbedrijf is een pluspunt. Je bent communicatief vaardig in het Nederlands en Engels. Daarnaast heb je een communicatieve ingesteldheid en werk je planmatig. Je bent flexibel en stressbestendig. Tot slot ben je ook een kwaliteitsgerichte persoon met een sterke drive om te presteren.

Wat kan je verwachten?

Als Teamleader Productie kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen.

Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Matthias Kegels op het nummer +32 (0)4 76 35 74 35 of via matthias.kegels(@)jeffersonwells.be.

Technical Buyer

  • Location: Halle
  • Type: Contracting
  • Job #19068

Technical Buyer

Fixed Contract – Region Halle 

#machinebuilding #buyer #customerrelations

Have you always been passionate about building customer relations, negotiating and engineering? Are you looking for a varied job with a lot of challenges within the industrial sector? This job might be something for you!

We are looking for a Technical Buyer for an international player, based in the area of Halle. The company is known for its advanced process technologies for the food and pharmaceutical sectors Are you ready for this challenge and you want to face it with Jefferson Wells? Read on!

Your responsibilities?

As Technical Buyer, you are responsible for leading the purchasing process to fulfill the requirements of the production using traditional and non-traditional methods. Your duties will consist of several diverse activities:

  • Understanding & analyzing of technical drawings (metal/plastic parts & assembly).
  • Manage the buying process including sourcing planning, quotation process, negotiate contracts, ….
  • Improve prices and terms of business with suppliers and review opportunities to make business savings.
  • When needed, expediting purchase orders to support fulfilment of production schedules and spare parts orders
  • Align expectations with Mechanical Engineering, Project management and support Engineering / Production Team on new ideas & new developments
  • Ensure professional and consistent approach is taken in relation to all supplier relationships
  • Ensure compliance to company guidelines, purchasing policies and procedures

Who are you?

For you to be able to perfectly execute the responsibilities of a Technical Buyer you preferably have a bachelors's degree in Engineering. A minimum of 5 years’ experience as a buyer within the industrial sector is required. As a professional you combine a strong technical insight with a commercial flair. Compliance, integrity, and respect are your core values and you’re punctual. Because you work in an international environment you must have a good knowledge of English. Every other language you know is seen as a great asset! 

What can you expect?

As a Technical Buyer you’ll work in a dynamic and open working environment with pleasant colleagues. Furthermore, you’ll receive an attractive salary with an extensive package of fringe benefits and an immediate fixed contract. Finally, you’ll enjoy the opportunity for personal and professional development through internal training and education.

Does this position meet your expectations? Then apply directly via the website or contact Sara Van Den Bossche on +32 (0)4 72 79 10 42 or via sara.vandenbossche(@)jeffersonwells.be.

Regulatory Affairs MDR

  • Location: Diegem
  • Type: Contracting
  • Job #19048

Regulatory Affairs MDR

Contracting – Flemish Brabant

Your responsibilities? 

With a good knowledge of Regulatory Affairs in the EU, this role will proactively coordinate and track the alignment of country-specific activities and liaise with relevant cross-functional stakeholders to support regulatory MDR Project deliverables for the BU.

Under moderate supervision and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position:
 

  • Provides strategic guidance to the Business Unit related to regulatory requirements and develops recommendations pertinent to the Franchise in accordance with regulations and relevant guidelines
  • Ensures the timely execution of regulatory implementation activities and associated projects
  • Provides clear and timely communication of new and changing requirements to the Franchise regulatory teams
  • Educates Franchise Associates on EU requirements and integrating those requirements into Franchise procedures
  • Organizes and maintains reporting schedules, trackers and systems
  • Develops and sustains relationships with RA affiliates, contributing to the development and execution of local strategy. This includes planning, prioritization and preparation of responses to regulatory agencies' questions and other correspondence
  • Drives consistency across all businesses within the BU for technical documentation creation and adherence to procedures
  • Supports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges and process improvements throughout the program
  • Supports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule
  • Develops and maintains constructive and cooperative working relationships with business functions in the organization
  • Identifies and facilitates continuous improvement activities
  • Develops solutions to a variety of problems of extreme complexity in which data analysis requires an evaluation of intangible variables
  • Writes, reviews and revises company SOPs as required, recommending adjustments to processes to improve efficiency or align with compliance requirements
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Your profile?

  • University degree in Science, Engineering, Technical or Biomedical field (or equivalent degree with adequate experience)
  • 6-8 years’ experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries
  • Good knowledge of medical device regulatory requirements in the EU
  • Ability to work effectively in a highly matrixed organization
  • Ability to work autonomously
  • Project Management Skills
  • Strategic thinking and ability to partner and influence key stakeholders
  • Highly skilled in establishing partnerships with Regional and Franchise colleagues
  • Strong communication, influencing and presentation skills
  • Strong results-orientated and sense of urgency
  • Strong ability to build constructive and cooperative working relationships
  • Excellent written and verbal communications skills in English (required) 

Our offer?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Anaïs Malikian, [email protected]

Deputy Pharmacist

  • Location: Halle
  • Type: Perm
  • Job #14660

Deputy Pharmacist

Vast Contract – Regio Halle
#farma #QA #RA

Heb je een passie voor quality management en regulatory affiars? Neem je graag een grote hoeveelheid aan verantwoordelijkheden op? Haal je voldoening en energie uit een gevarieerd takenpakket? Lees dan vooral verder!

Onze partner is op zoek naar een Deputy Pharmacist om hun quality team te versterken. Dit gerenommeerd distributiebedrijf gelegen in Halle is internationaal actief binnen de farmaceutische sector en staat bekend omwille van hun dynamische, open en familiale werkomgeving.

Jouw verantwoordelijkheden?

Als Deputy Pharmacist kom je terecht in een aangename omgeving en krijg je de verantwoordelijkheid over de monitoring en de naleving van regulatory affairs voor de farmaceutische- en gezondheidsproducten. Jouw takenpakket bestaat uit een aantal gevarieerde activiteiten:

  • De status controleren (vrijgegeven/niet vrijgegeven) van inkomende en opgeslagen producten en ervoor zorgen dat statuswijzigingen voldoen aan de toepasselijke wetgeving
  • Optreden als QP voor de vrijgave van EU-batchproducten
  • Het besluitvormingsproces beheren voor geretourneerde goederen
  • Toezicht houden op de fabricageactiviteiten volgens de huidige indien nodig optreden als QP voor dergelijke activiteiten
  • De farmaceutische gegevens controleren van gedistribueerde producten
  • Toezien op het terugroepen van producten en opstellen van incidentenrapporten
  • De RP/QP assisteren bij de follow-up van klanten en regelgevingszaken, en bijstaan in alle contacten met het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
  • Ondersteunen van business development inzake farmaceutische en regelgevende kwesties; ondersteunen bij het opstellen/herzien van technische overeenkomsten
  • Bijdragen tot de ontwikkeling van het ISO 9001-kwaliteitssysteem
  • Gxp Audit organiseren en begeleiden
  • De taken van de RP/QP volledig overnemen bij afwezigheid

Wie ben je?

Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Deputy Pharmacist idealiter over een master industriële farmacie. Daarnaast heb je enkele jaren relevante werkervaring in QA. Ook heb je een operationele kennis van GDP, GMP en kwaliteitsmanagementsystemen. Je bent communicatief vaardig in het Nederlands en Engels. Verder ben je analytisch en probleemoplossend ingesteld met oog voor detail en nauwkeurigheid. Tot slot ga je klantgericht te werk en kan je vlot prioriteiten leggen.

Wat kan je verwachten?

Als Deputy Pharmacist kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen.

Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Matthias Kegels op het nummer +32 (0)4 76 35 74 35 of via matthias.kegels(@)jeffersonwells.be.

QA Specialist

  • Location: Mechelen
  • Type: Perm
  • Job #17157

QA Specialist

Vast Contract – Regio Mechelen
#farma #quality #QA

Heb je ervaring met kwaliteitssystemen in de farmaceutische sector? Heb je een sterk analytische denkvermogen en zoek je meer verantwoordelijkheid? Beschik je over een goede kennis van kwaliteitsnormen- en wetgevingen? Lees dan vooral verder!

Onze partner is op zoek naar een QA Specialist om hun kwaliteitsteam te versterken. Dit toonaangevend distributiebedrijf gelegen in de regio Mechelen is internationaal actief binnen de farmaceutische sector.

Jouw verantwoordelijkheden?

Als QA Specialist kom je terecht in een aangename omgeving en krijg je de verantwoordelijkheid over de coördinatie, monitoring en uitvoering van kwaliteitsverbeteringen. Jouw takenpakket bestaat uit een aantal gevarieerde activiteiten:

  • Adviseren op de integratie van GMP, GDP, ISO en klantenbehoeften in processen, procedures en instructies
  • Technische overeenkomsten met klanten en leveranciers reviewen
  • Kwaliteitsproblemen (klachten, deviaties, etc.) evalueren doormiddel van impactanalyses en CAPA’s
  • Change management en risicobepalingen coördineren
  • Reviewen en goedkeuren van productregistraties en documentatie van de goederen
  • Coördineren en begeleiden van interne en externe audits
  • Uitvoeren van lokale releases, administratieve handling, en andere operationele kwaliteitstaken
  • Opstellen en implementeren van KPI’s
  • Training en opleiding voorzien indien nodig
  • Rechtstreeks rapporteren aan en nauw samenwerken met de QA Manager

Wie ben je?

Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als QA Specialist over een master in de wetenschappen (industrieel apotheker, bio-ingenieur, industrieel ingenieur) aangevuld met enkele jaren relevante werkervaring in GDP, GMP en QMS. Je bent communicatief vaardig in het Nederlands en Engels. Je werkt graag nauwkeurig en klantgericht. Daarnaast heb je een analytische en probleemoplossende ingesteldheid en ga je flexibel te werk. Tot slot ben je ook een stressbestendig persoon die zowel zelfstandig als in teamverband vlot aan de slag kan.

Wat kan je verwachten?

Als QA Specialist kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen.

Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Matthias Kegels op het nummer +32 (0)4 76 35 74 35 of via matthias.kegels(@)jeffersonwells.be

Operational Purchasing Team Lead supply chain Nl/Fr

  • Location: Machelen
  • Type: Perm
  • Job #18548

Operational Purchasing Team Lead supply chain Nl/Fr

CDI – Flemish Brabant
#purchaser #buyer #aankoper #acheteur #supplychain #teamleader #purchasing #achat #operational

Are you looking for a job opportunity where you can manage purchasing and supply chain ? Do you like to be near the front line and have an important role in the success of your company ? Do you like to share your best practice with colleagues? You are maybe the new Operational Purchasing Team Leader supply chain of my partner.

You integrate the purchase department and manage a team of several purchaser.

What are your responsabilities?

You contribute to the creation and implementation of best practice purchasing principles, policies, processes and procedures to improve operational and financial performance.

You manage a team of purchasers, you wake to up skilling their competencies and co-ordinate the procurement activities liaising with internal stakeholders and suppliers.

You are looking for new sources of components and you are a solution finder. You translate the sales forecast in supply. You prioritize procurement needs, inventory reduction activities and procurement parameter updates.

You act as a key user related to daily used modules in ERP system

  • Document procurement processes, instructions and improvements
  • Train the team and key-users, communicate the purchasing management process and any other relevant areas as required

You ensure a strong communication between teams to facilitate exchange of information, changes and improvements.

Who are you?

You have at least a bachelor’s degree in supply chain, purchasing or relevant field and a minimum of 5 years of experience in procurement and/or demand planning environment.

You have a strong knowledge of supply & Demand and operational purchasing, a good knowledge of sourcing and vendor management, an ability to analyze and manipulate complex data, assess issues and develop action plans to bring quick and effective solutions.

An experience in a electronical or electromechanical company is an asset.

You speak fluently Dutch, French and English and are able to discuss as well as with director than worker.

What can you expect?

You will be part of a growing company specialized on electrotechnical equipment. You will integrate a company with a good spirit and a dynamic environment. You will receive a package salary depending on your competencies and study.

Clinical Research Specialist

  • Location: Diegem
  • Type: Contracting
  • Job #18346

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Clinical Research Specialist

The Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Location: Diegem

Scope of work:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:

• Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, under supervision;

• Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;

• May serve as the primary contact for clinical trial sites (e.g. site management);

• Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);

• Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;

• Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;

• Interfaces and collaborates with Clinical Research Associates (CRAs);

• Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;

• Assists in clinical data review to prepare data for statistical analyses and publications;

• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;

• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;

• Assists in tracking assigned project budgets;

• May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);

• May perform other duties assigned as needed;

• Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;

• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

• Should develop a strong understanding of the pipeline, product portfolio and business needs;

• Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.

Who are you?

Education

  • Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

 

Experience

• BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.

• Previous experience in clinical research or equivalent is desired.

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

• Clinical/medical background is a plus.

• Medical device experience is a plus.

 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES & AFFILIATIONS

Functional and Technical Competencies:

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;

• Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;

• Presentation and technical writing skills;

• Written and oral English communication skills.

 

Leadership Competencies:

Strong leadership required in alignment with intenal Leadership Imperatives:

• Connect – Develop collaborative relationships with key internal and external stakeholders.

• Shape – Actively participate in departmental process improvement activities.

• Lead – Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

• Deliver – Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

 

LOCATION & TRAVEL REQUIREMENTS

• Primary location for this position is Diegem. At management discretion, the position may be performed remotely.

• Ability to travel approximately 20% depending on the phase of the program.

 

EXTERNAL INTERACTIONS

• Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.

• May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Clinical Research Manager

  • Location: Diegem
  • Type: Contracting
  • Job #18345

JJJP00011538

 

Description:

 

Clinical Research Manager (Clinical R&D)

JOB SUMMARY
This Clinical Research Manager will be responsible for clinical trial management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
• Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;
• Ensures applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
• Is responsible for team’s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel;
• Is responsible for clinical data review to prepare data for statistical analyses and publications;
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
• Ensures input and strong alignment from key regional Clinical R&D leads and other strategically important countries/ regions in the development of the EGS/ EDS;
• Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
• Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.;
• Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
• Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc. including during sponsor regulatory inspections;
• Serves as the clinical representative on a New Product Development team;
• Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
• Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
• Is responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition;
• Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;
• Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
• May perform other duties assigned as needed;
• Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Should develop a strong understanding of the pipeline, product portfolio and business needs;
• Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.

EXPERIENCE AND EDUCATION
Education
• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience
• A minimum of 8 years related scientific/ technical experience, including leadership/management role within Clinical Research.
• Significant previous experience in clinical project leadership across multiple studies/ programs is required.
• Experience working well with cross-functional teams is required.
• Experience with budget planning, tracking and control is required.
• Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background is a plus.
• A minimum of 1-2 year people management related experience is a plus.
• Medical device experience is highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES & AFFILIATIONS
Functional and Technical Competencies:
• Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects, including complex and/ or transformational projects;Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral English communication skills;
• Comprehensive understanding of clinical trial regulations across multiple regions;
• Demonstrates competencies in the following area are required:
o Ability to lead teams to deliver critical milestones, including complex projects
o Strong project management skills with ability to handle multiple projects
o Strong people management skills
o Change agent in team development and progression

Leadership Competencies:
Strong leadership required in alignment with J&J Leadership Imperatives:
• Connect – Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS. Create strong and productive partnership with resource providers and vendors.
• Shape – Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.
• Lead – Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.
• Deliver – Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
• Reports to Clinical Research Associate Director or Clinical Research Director
• Functions that this position is responsible for (direct/ indirect management):
o Clinical Study Administrator
o Clinical Research Specialist
o Senior Clinical Research Specialist
o Clinical Research Leader
• Expected to build collaborative relationships with key internal partners and stakeholders. Ref. duties and responsibilities section.

LOCATION & TRAVEL REQUIREMENTS
• Primary location for this position is Diegem.
• Ability to travel approximately 20-25% depending on the phase of the program.

EXTERNAL INTERACTIONS
• Interaction with physicians and research staff at centers selected for involvement in clinical research

Education Required  

Doctorate (PHD) or Equivalent

Job Function  

R&D

Job Subfunction  

Clinical Research MD

Site Access  

Off-Site with Site Access

Work Experience  

Generally Requires 8-10 Years Work Experience

Permanent Salary Equivalent Rate  

0,00

QA GMP Auditor

  • Location: Asse
  • Type: Contracting
  • Job #17750

QA GMP Auditor

Brabant Flamand – Consultance

#QA #audits #laboratoire #CAPA #documentation #GMP #ISO17025

Notre partenaire est actuellement à la recherche d’un QA GMP Auditor pour venir renforcer son équipe. Il s’agit d’une entreprise internationale d’inspection, de vérification, de testing et de certification.

Quelles sont vos responsabilités ?

En tant que QA GMP Auditor, vous êtes en charge de mener des audits internes et externes (clients et autorités). Pour exceller dans ce rôle, voici vos principales tâches :

  • Conduite et suivi des audits internes dans les laboratoires (chimie et Projects & Stabilities) :
    • Mène des audits auprès du personnel de laboratoires, relève les incohérences, les dysfonctionnements
    • Evalue les systèmes et les techniques de travail utilisées en regard des procédures et législations applicables
    • Rédige les rapports d’audits, les conclusions et assure le suivi des actions correctives et préventives (CAPAs)
  • Coordination des audits clients ou autorités pour le laboratoire (chimie et Projects & Stabilities) :
    • Accompagne les auditeurs externes et répond à leurs questions
    • Gère les observations des auditeurs/inspecteurs et assigne celles-ci aux personnes concernées en co-évaluant la pertinence des recommandations avec les managers de laboratoires
  • Revue de la documentation relative aux études et en vérifie la conformité par rapport aux Documents Qualité (Procédures, Working Instructions, …), normes GMP et ISO17025 et révise les protocoles et rapports de vérification/tests/études de stabilités
  • Revue des documents spécifiques relatifs aux non-conformités (Déviations, plaintes, OOX, …)
  • Revue des documents qualité telles que les procédures opérationnelles, les working instructions, les formulaires et les templates
  • Support dans le traitement des plaintes clients

Qui êtes-vous ?

Vous êtes titulaire d’un diplôme de master en sciences (ou équivalent). Vous avez une expérience dans l’assurance qualité (audits) dans l’industrie pharmaceutique. Vous avez également une bonne connaissance des normes GMP et ISO 17025. Vous parlez couramment français et anglais. Vous êtes une personne organisée, précise et méticuleuse.

Que pouvez-vous attendre ?

Jefferson Wells vous offre un contrat permanent en tant que consultant avec un package salarial attractif. Nous serons votre partenaire tout au long de votre carrière.

Vous êtes intéressé.e par cette opportunité ? Nous vous invitons à postuler. Vous avez des questions ? Vous pouvez contacter Sophie Rolis, [email protected]

Analyste en Microbiologie

  • Location: Asse
  • Type: Contracting
  • Job #17749

Analyste en Microbiologie

Brabant Flamand – Consultance

#microbiologie #laboratoire #QC #solutions #milieuxdeculture #autoclave #LAL #GMP

Notre partenaire est actuellement à la recherche d’un Analyste en Microbiologie pour venir renforcer son équipe. Il s’agit d’une entreprise internationale d’inspection, de vérification, de testing et de certification.

Quelles sont vos responsabilités ?

En tant qu’Analyste en Microbiologie, vous êtes en charge de la réalisation des contrôles qualité, vous rédigez les rapports d’analyse, et vous contribuez au bon fonctionnement du laboratoire. Pour exceller dans ce rôle, voici vos principales tâches :

  • Prend connaissance de la feuille de travail, par échantillon et par client, qui inclut le délai, le mode de préparation des échantillons, la toxicité du produit, la description des tests, les spécifications à rencontrer et toutes informations utiles au bon déroulement de l’analyse
  • Prépare les solutions et milieux de culture
  • Vérifie le statut des équipements
  • Manipule les échantillons en vue de faire l’analyse
  • Prévient la hiérarchie en cas de problèmes ou de résultats hors spécifications
  • Participe aux investigations
  • Rédige son rapport d’analyses
  • Lit et interprète les résultats obtenus
  • Constitue un dossier complet en vue de la revue des données
  • Contribue à maintenir l’ordre et la propreté du laboratoire
  • Rédige les procédures d’utilisation des équipements qui lui sont confiés
  • Suit les échéances de qualification

Qui êtes-vous ?

Vous êtes titulaire d’un diplôme de bachelier en sciences (ou équivalent). Vous avez une expérience dans un laboratoire de microbiologie. Vous avez une connaissance des méthodes de microbiologie (hotte à flux laminaires, pompe, autoclave, filtration sur membrane, LAL, dénombrements microbiens, identifications). Vous avez également une bonne connaissance des normes GMP. Vous parlez couramment français et vous connaissez l’anglais scientifique. Vous êtes une personne organisée, précise et méticuleuse.

Que pouvez-vous attendre ?

Jefferson Wells vous offre un contrat permanent en tant que consultant avec un package salarial attractif. Nous serons votre partenaire tout au long de votre carrière.

Vous êtes intéressé.e par cette opportunité ? Nous vous invitons à postuler. Vous avez des questions ? Vous pouvez contacter Sophie Rolis, [email protected]