Be the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) to allow assessment.
Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, SpiderImpact) and track the vendor’s performance
Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging
Be the point of contact for post-release vendor issues (supply chain, distribution, etc.)
As required provide Operational QA support to other vendors
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Act as a coach for VQL’s with less experience.
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Act as Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process
Your profile:
Master’s degree in Sciences
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Must be able to work independently and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
Possess good auditing capabilities and skills.
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Must have the ability to manage projects / activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
Root cause and risk management/assessment skills
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 or send me your CV, [email protected]
Document and Records Management Expert Contracting – Brabant Wallon Your Responsibilities
Perform quality control on non-clinical documents (protocols, amendments, reports, etc.).
Ensure compliance and readiness of documents for regulatory submissions.
Upload, index, and track documents in the Veeva Vault EDMS.
Oversee the document lifecycle, ensuring adherence to quality standards and GLP requirements.
Liaise with stakeholders (authors, QA, RA, etc.) to follow up on corrections and approvals.
Provide training and guidance to internal users on good documentation practices.
Participate in process reviews and continuous improvement initiatives for documentation workflows.
Your Profile
Minimum 8 years of experience in the pharmaceutical industry.
Strong background in regulated documentation management (GLP, GCP, etc.).
Deep understanding of non-clinical documentation and its lifecycle.
Hands-on experience with Electronic Document Management Systems (EDMS), preferably Veeva Vault.
Familiarity with regulatory requirements for submission-ready documents.
High level of digital literacy.
Comfortable working in high-compliance, traceability-focused environments.
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 or send me your CV, [email protected]
Vous avez de l'expérience dans la gestion de fournisseurs, l'amélioration des performances logistiques et la conduite d'audits de capacité ? Vous êtes à l’aise dans un rôle de coordination, d’analyse et de coaching ? Cette opportunité est pour vous !
Notre partenaire, un leader international dans le secteur de l’industrie / transport, recherche un Supplier Delivery Performance Manager pour renforcer son équipe basée à Bruges. L’entreprise est reconnue pour ses innovations technologiques, sa culture de formation continue et son engagement durable.
Vos responsabilités ?
En tant que Supplier Delivery Performance Manager (SDPM), vous êtes responsable de la fiabilité des livraisons fournisseurs et vous jouez un rôle clé dans la prévention et la gestion des risques logistiques.
Vos tâches principales incluent :
Évaluer la capacité de production et la maturité supply chain des fournisseurs via des audits ciblés.
Analyser les causes racines des non-performances et mettre en place des plans d'action.
Gérer les crises de livraison (mono-site ou multi-site).
Piloter des plans d’amélioration pour les fournisseurs sous-performants.
Accompagner et former les Material Planners aux méthodes SDPM.
Participer au développement de la roadmap APSYS et à la standardisation des processus.
Travailler en collaboration avec les parties prenantes lors de problématiques majeures.
Respecter et promouvoir les politiques EHS et les règles d’éthique Alstom.
Votre profil ?
Vous êtes titulaire d’un diplôme universitaire (Master ou Bachelier) en logistique, ingénierie, économie ou domaine équivalent et justifiez d’une expérience dans un environnement industriel ou supply chain.
En plus de cela :
Vous avez une bonne expérience en gestion des fournisseurs et gestion des risques.
Vous êtes analytique, orienté solution et bon communicateur.
Vous parlez couramment le français et l’anglais ; le néerlandais est un plus.
Vous travaillez de façon autonome et êtes résistant au stress.
Ce que nous vous offrons ?
Un contrat à durée indéterminée dans un environnement dynamique et international avec :
Horaire flexible et possibilité de télétravail
Assurance groupe et hospitalisation
Plan cafétéria (leasing voiture/vélo, électronique, coaching, …)
Opportunités de développement personnel via des formations internes
Vous vous reconnaissez dans ce profil ? Postulez directement via notre site web ou contactez Jan au +32 (0)494 16 31 09 ou via jan.vangrembergen@jeffersonwells.be
Service Manager Vast contract – regio Drongen #ServiceManagement #TeamLeadership #TechnicalProjects
Ben jij een geboren leider met een passie voor technologie? Heb je ervaring in het leiden van service teams en wil je werken in een internationale omgeving met uitdagende technische projecten? Dan is deze job zeker iets voor jou!
Voor een toonaangevend bedrijf regio Drongen, gespecialiseerd in industriële technologieoplossingen, zijn we op zoek naar een Service Manager (m/v/x). Klaar voor deze uitdaging? Lees dan zeker verder!
Jouw verantwoordelijkheden? Als Service Manager ben je verantwoordelijk voor het leiden van een team van service engineers die wereldwijd machines installeren en in bedrijf stellen. Je hebt een natuurlijke leiderschapsstijl en bent een coach voor je team, waarbij je de organisatie en je teamleden ondersteunt door middel van:
Resourcemanagement, zoals het inplannen van personeel, forecasting en het regelen van reizen.
Het beheren van escalaties en het geven van trainingen aan je team.
Ondersteunen van de uitbreiding van de wereldwijde spare parts-business door commerciële opportuniteiten te spotten en te benutten, en lange-termijn klantrelaties te onderhouden.
Je zorgt voor trainingen en blijft op de hoogte van de laatste trends in de industrie.
Het optimaliseren van serviceprocessen, het in kaart brengen van verbeterpunten en workflows optimaliseren.
Rapporteren aan de Business Managers en Business Unit Director en nauw samenwerken met de sales- en projectmanagers.
Wie ben je? Je beschikt over een masterdiploma in Elektromechanica of een gelijkwaardige ervaring. Je hebt ervaring met het installeren en inbedrijfstellen van grote Capex-projecten in een technische omgeving. Verder ben je gepassioneerd door technologie, klantgericht en heb je een sterk probleemoplossend vermogen. Proactief handelen en een meester zijn in planning is essentieel voor deze functie. Je bent bereid om tot 20% van de tijd internationaal te reizen en bent vloeiend in het Engels (kennis van andere talen is een pluspunt).
Wat kan je verwachten? Als Service Manager kom je terecht in een dynamisch en innovatief bedrijf dat sterk inzet op technologie en service excellence. Je krijgt een aantrekkelijk loonpakket met extralegale voordelen en een vast contract van onbepaalde duur. Daarnaast biedt het bedrijf volop kansen voor persoonlijke en professionele ontwikkeling door middel van interne opleidingen en trainingen.
Voldoet deze vacature aan jouw verwachtingen? Solliciteer direct via de website of contacteer Jan Van Grembergen op het nummer (+32) 0494 16 31 09 of stuur je CV naar jan.vangrembergen@Jeffersonwells.be.
Pour notre client spécialisé dans le secteur de l’industrie lourde, nous sommes activement à la recherche d’un responsable maintenance électrique.
Quelles sont vos responsabilités ?
1. Organisation de la maintenance des équipements du Q&T
Veille au respect des consignes de sécurité, à la conformité des équipements, analyse les écarts, propose et suit les actions correctives éventuelles
Déploie une stratégie de maintenance compatible avec les objectifs de l’usine et les moyens à sa disposition :
Etablit les criticités des équipements dont il a la charge
Veille à ce que les plans de maintenance soient consistants, les améliore ou les met à jour le cas échéant
Organise et suit l’exécution des plans de maintenance
Veille à la bonne adéquation entre les besoins et les ressources disponibles (humaines et financières). Met en évidence les écarts éventuels et développe des stratégies permettant de rétablir l’équilibre le cas échéant.
Utilise les outils de la maintenance professionnelle
Utilise la GMAO comme outil de suivi des activités de maintenance – s’assure que l’historique d’intervention est conservé
Organise l’analyse de défaillances, valide ou réalise les analyses, veille au suivi des actions correctives
Déploie une approche centrée sur la fiabilité (AMDEC, ajustement des niveaux de pièces de réserve, criticité des équipements,)
Veille à ce qu’un planning d’intervention soit en place et suivi
Suit les indicateurs de la maintenance dans un tableau de bord (réalisation du préventif, heures de curatif, MTBF, MTTR, respect du planning, retard de préventif, taux d’arrêt,…)
Gère le budget qui lui est alloué et en collaboration avec les achats et le controlling, réfléchit aux solutions qui permettent d’optimiser les coûts (établissement de contrats de maintenance,…)
2. Travail d’équipe / Management et leadership
Anime l’équipe de maintenance électrique et collabore avec les équipes de dépannage. Veille à conserver une ambiance de travail sereine et constructive dans le département et avec les autres départements.
Développe les compétences de ses collaborateurs. Identifie les points d’amélioration, construit la matrice des compétences, propose des plans des formation, donne lui-même des petites leçons ponctuelles
Veille au transfert d’information entre les départements et à l’utilisation du retour d’expérience comme élément d’amélioration continue
Assure le suivi opérationnel de son équipe (Validation des congés,…)
3. Projets d’améliorations
Organise la réalisation les modifications d’équipements nécessaires afin d’améliorer la performance, la sécurité, …
Veille à l’intégration des modifications techniques dans la GMAO, les plans & documentation technique
Participe régulièrement aux réunions du département maintenance et capture les idées d’améliorations pertinentes pour leur donner un suivi approprié (demandes CAPEX, GEGR, modifications d’équipements,)
4. Lien avec les départements Process et qualité
Participe aux revues process et qualité en tant que représentant du département technique.
Porte le plan d’action de la maintenance découlant de l’interface Maintenance / Qualité / Process
5. Veille technologique
Se tient informé des dernières évolutions technologiques concernant les équipements de la ligne. Est force de proposition pour faire évoluer nos équipements.
Tient à jour un cahier de l’obsolescence des équipements de l’usine. Etablit les criticités et alimente les plans CAPEX à 5 ans.
6. Mise à jour documentaire
Veille à ce que la documentation technique disponible reste à jour. Organise les mises à jour au besoin.
Collabore avec le responsable des archives pour assurer que les documents techniques disponibles pour les équipes opérationnelles sont à jour.
Qui êtes-vous ?
1. Niveau de formation (Diplôme)
Ingénieur industriel électricien ou électromécanicien avec affinité électrique
2. Connaissances particulières
Electricité industrielle : Moteurs CC ou CA – régulations & drives – instrumentation – basse, moyenne et haute tension – Automatismes industriels…
Connaissance de base d’un logiciel de GMAO et expérience dans un département de maintenance
Outils d’analyse de panne, de résolution de problèmes, de priorisation des modes de défaillance,… (arbres des causes, Why-Why, AMDEC,…)
3. Aptitudes
Fait preuve d’autonomie dans son travail
Possède un leadership naturel lui permettant d’obtenir l’adhésion de ses équipes mais également de travailler en transversal avec d’autres départements
Autonomie et rigueur pour suivre de multiples dossiers techniques
Curieux techniquement et ouvert à d’autres disciplines (automatismes, mécanique, hydraulique, climatisation, combustion,…)
Capacité à utiliser les outils informatiques (SAP, Excel, Outlook,…)
Aptitudes à communiquer efficacement avec divers interlocuteurs (achats, techniciens du service, fournisseurs,…)
Disponible et flexible, s’adapte aux besoins de l’organisation
4. Expérience professionnelle
Expérience professionnelle de 3 ans au moins dans un département de maintenance
Que pouvez-vous espérer ?
Nous vous offrons un contrat à durée indéterminée ainsi qu’un package salarial attractif. Vous profiterez également de l’opportunité de vous développer personnellement et professionnellement à travers des formations internes.
Process Engineer Brabant Walloon – contracting Our partner is looking for a Process Engineer to join its team. This international company is well-known for its pharmaceuticals. Your responsibilities? In coordination with Engineering Office and Project Management, you will provide expertise in the implementation of good engineering & design practices and solutions to support design, execution and commissioning / qualification phases of CapEx Projects. You will ensure correct design, construction, commissioning, and qualification in full compliance with internal requirements and authorities' requirement of Secondary equipment’s and Aseptic technologies package. Related to these packages, it includes:
Being the internal representative for all Secondary equipment’s and Aseptic technologies-related activities and installations
Supporting the E.O in management of activities related to this package
Ensuring alignment between E.O and the company Specification and Guidance
Reviewing design and technical documentation
Following-up construction & all testing activities falling under the package’ scope
Ensure systems start-up and punch list solving
Writing and executing commissioning and qualification protocols/reports
Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
Facilitating handover process towards the end user
Your profile?
Engineering degree with 5 years’ experience as Process Engineer in Secondary Equipment’s and Aseptic Technologies domains.
Strong Experience in the Pharmaceutical industry and cGMP environment.
Definition of functional, technical and quality requirements.
Realization of reviews of process studies, P&ID’s and layouts
Oversight contractor's performance.
Integration of operability and EHS requirements at all design steps.
Preparation of the project testing, commissioning and inspection requirements
Organize legal conformity visits
On-site verification of execution according to good practices
Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…),..
Team working & Communication, Autonomy, Contractors' management.
Good project integration experience: organisation, schedule, qualification, validation, technologies.
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]
Our partner is Belgium's high-voltage electricity transmission system operator. Based in Brussels, they are looking for a Project Engineer Civil Works Service
Your responsabilities
Develop technical solutions during the design phase
Prepare and manage project budgets.
Provide input for scheduling and defining the work scenarios for the project and coordinating with other projects.
Coordinate and follow up on architectural plans for permit applications.
Manage, coordinate, control, and follow up on execution studies, including the structural stability studies of civil constructions and the preparation of plans.
Inform designers during the detailed study phase about the technical requirements of the project, ensuring correct execution of the scope.
Supervise and monitor external engineering partners.
Draft the technical specifications and bill of quantities for contractor selection.
During the execution phase, support the project manager in resolving specific technical issues.
Collect feedback and organize the final review of the completed study. Provide input for the acceptance of works.
Take full responsibility for the quality of civil engineering studies
Your profile
Excellent knowledge of Dutch and French
Degree in Civil Engineering or equivalent
Strong focus on quality
Well-organized, flexible, with strong communication skills and a team-oriented mindset
Strong affinity with construction techniques, soil mechanics, and knowledge of structural stability calculations
Capable of managing several projects simultaneously
Proactive in project task management and problem-solving approach
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? Don't hesitate to apply
Be the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) to allow assessment.
Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, QuickScore) and track the vendor’s performance
Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging.
Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL’s on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
As required provide Operational QA support to vendors for process, equipment and facilities qualification and project support
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Acts as a coach for VQL’s with less experience.
Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process
Act as coach for the direct reports, perform personal development discussions and manage year-end evaluations and objectives setting (if applicable).
Oversee the VQL activities performed by the direct reports (if applicable).
Your profile:
Master's Degree in Sciences
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
Possess good auditing capabilities and skills
Must have the ability to manage projects/ activities across global geographies within the area of expertise.
Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
Root cause and risk management/assessment skills Problem Solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
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 or send me your CV, [email protected]
Autonomously manage and execute daily laboratory activities related to method development, validation, and transfers.
Contribute to release and stability testing in relation to the project, as appropriate.
Prepare, review, and approve documentation (procedures, protocols, reports).
Analyze experimental results.
Verify data accuracy.
Present and discuss results in project team meetings.
Perform all activities in compliance with GMP/HSE rules and regulatory requirements for each development phase of the product.
Your Profile
Master’s or Bachelor’s degree in biochemistry or analytical chemistry.
Proven expertise, preferably in the biotech industry.
Strong, proven laboratory skills.
Good knowledge of protein chemistry and techniques for separating polymers in a protein matrix.
Practical experience and expertise in at least one of the following analytical techniques:
Chromatography (Size-exclusion, Reverse-phase, Affinity, Ion exchange, HILIC, or HIC).
Electrophoresis (Capillary: CGE, CzE, iCE, or MauriCE).
Expertise in analytical method development and validation.
Ability to work autonomously in day-to-day tasks.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
A good knowledge of GLP/GMP rules is a plus.
Good English skills (both written and oral) are recommended for reports and communication.
Ability to manage multiple priorities and prioritize effectively.
Strong interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
Ability to work in a matrix and customer-oriented environment.
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 or send me your CV, [email protected]
Primary packaging systems innovation and new products development management :
New primary packaging systems development management in line with the strategy, “Pipeline Devices & Delivery Systems” and technologic/scientific platforms objectives and according to established working processes.
Clinical medical devices design and assessment
Primary packaging systems life cycle & sustaining management :
Primary packaging systems sustaining and life cycle management coordination and support to all operation sites and CMO’s.
Competitors pharmaceuticals primary packaging systems benchmarking management :
Competitors primary packaging systems portfolio analyze & characterization.
Primary packaging materials, components and technology scouting and assessment according to defined priorities
Planning, implementation and documentation to maintain and set up the systems (processes, resources, equipment) of the organizational unit
Where applicable: maintenance of and responsibility for the SOP processes assigned to the unit and direct sub-processes thereof
The job holder informs his superior about significant changes and progress without delay on a regular basis and in emergencies.
Within the unit and/or projects the job holder ensures that the internal regulations and the national laws and ordinances concerning occupational safety, accident prevention, waste removal and disposal, and environmental protection are observed
In the planning, performance and documentation of his work within the unit the job holder ensures that the applicable internal rules (Standard Operating Instructions, SOP) and the applicable national and international laws, regulations and directives are observed
The job holder participates in the necessary training defined for his job, e.g. SOP training sessions, GMP training sessions, projects management, technical/scientific trainings, conferences, etc
Your profile:
Minimum of 5 years working in the pharmaceutical/biologics/medical primary packaging industry. Operational GMP or quality experience would be a distinct advantage
Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur. and JP standards, Food-contact legislations
Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems
Pharmaceutical business experience and familiarity with competitive landscape of primary packaging development process, regulatory requirements
Experience in global projects, ideally with USA or EU operational, HS&E processes and procedures
Proven track record in project management / Project Management certification will be a distinct advantage
Fluency in French & English
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 or send me your CV, [email protected]
