You have experience in quality assurance and validation in the pharma sector? You have an eye for details and for work well done? Keep reading your future job description.
Our partner is looking for a QA Validation to join its team. This international company is well-known for its pharmaceuticals and vaccines.
Your responsibilities?
As QA Validation, you will Provide QA support and oversight to validation activities according to validation procedures.
To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP)
To define the validation strategies through the change control process
To write and implement some validation documentation (VP, VSR)
To review and approve specific qualification and validation documentation (IQ, OQ, PQ, Risk Assessment, Periodic validation)
To ensure the correct application of the validation quality systems on the field and to define improvement plan as required
To support the production & technical services teams in the implementation of the validation activities
To ensure an efficient and compliant CVP implementation
To provide a compliance and business expertise for some specific technical subjects
Challenge, review and approve qualification and validation (IQ,OQ, PQ, equivalence certificate, requalification protocol/report) documentation and ensure they are written in accordance with the internal standards and procedures
Write some validation (VP, PQ, VSR)
Review Periodic Validation Review documentation according to the company standards and procedures
Ensure timely escalation to Management of critical issues during validation and/or project
Pro-actively identify potential quality and compliance risks and be pro-active in escalation.
Attend all project meetings as QA expert from a compliance point of view the Manufacturing Unit Product & Process, Production and QA Operations for validation topics.
Your profile?
Engineering or scientific background (or equivalent acquired through professional experience)
Experience QA and Equipment’s Validation in a GMP Pharma environment
Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety
Use a risk-based approach for problem solving and prioritization of tasks
Blow a quality and compliance mindset through the validation activities
Good communicator, autonomous and rigorous
Team player
Critical mind and quality oriented
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.
Accountable/ responsible for ensuring the facilities is compliant with regulations and the standard quality systems in place, in collaboration with the owners of each individual area, which includes :
Access, confined areas and material and people flows through the facilities
Pest control management for the building (periodic visit and non conformity management)
Environmental monitoring (viable and non-viable) of the GMP areas and utilities, being the SPOC for the GMP manufacturing area and representative in the EM periodic meeting, managing asssessment of non conformities with stakeholders, suggesting actions and follow up with SMEs, reviewing/generating the periodic trending, keeping an eye on an optimal cleaning of the facilities.
Unexpected facility/environment event management (quick status, decision, quick actions plan and coordination with all the SMEs)
Risk management
Gowning process
Training of people on standard processes related to facilities and general quality systems
Highlight and prepare key topics and issues at Quality meetings
Quality standards/regulations Gap analysis, risk and remediation plans management
Monthly Quality Lead Team meeting preparation and Lead
GMP training annual refresh for the Pilot Plant: collaboration on the content
Deviations and Change Controls management linked to all the listed systems, general quality topics
Continuous improvement management linked to all the listed systems, general quality topics
Are you the candidate we're looking for?
Minimum Bachelor’s degree in sciences with min. 10 years experience in a regulated pharmaceutical area is required
Experience in production or quality, dealing with quality systems is required
Excellent understanding in GMP related environment
Experience with environmental monitoring is required
Experience in Biopharmaceutical is an asset
Experience dealing with Deviations and Change Controls
Foster lean and efficient processes, by continously challenging status-quo and striving for improvements
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺
We can't wait to meet you, so don't wait any longer!
Our partner is looking for a Transformer Oils Expert to strengthen its teams.
Your responsibilities?
You will work closely with other experienced colleagues to optimize customer processes, troubleshoot issues, and provide operational support. Your responsibilities will include:
The interpretation of different transformer oil analyses and to issue reports with specific recommendations in order to follow-up the condition of a large fleet of power transformers situated in power plants, HV-grids and larger industrial sites worldwide
Be the key contact person for several important customers
Provide training to key customers on sampling and interpretation of transformer oil analyses
Follow up online monitoring and collaborate in further developing the existing platform and fleet
Possibility to participate to international working groups
Participate in projects in order to further develop the knowledge on oil analysis, and transformer condition monitoring.
As a Transformer Oils Expert, you will focus on acquiring competence and experience based on the company's strategy. You will be required to intervene on industrial sites in Belgium and abroad. This is an opportunity to work on cutting-edge technologies, and make a significant impact on our customers' operations.
Your profil?
A chemical engineering degree or equivalent experience
A minimum of 5 years of experience in oils analysis
A strong customer-orientation, you are creative, and able to solve complex problems by providing innovative and high-value-added solutions. You communicate effectively about the solutions you have developed.
An hands-on profile open for practical interventions
Good communication skills and fluent in Dutch, French and English
Team player mindset, capable of working on your own
Our offer? We offer you a permanent contract and an attractive salary package. You will also benefit from the opportunity to develop personally and professionally through in-house training.
Vast contract of freelance – Regio Gent #Maintenance #Ulltimo #Technicalplanning
Hou jij van een goede combinatie tussen technische werkvoorbereiding, het ondersteunen van techniekers en het begeleiden van leveranciers? Op zoek naar een gevarieerde job waarbij je actief mag meewerken aan het optimaliseren en implementeren van diverse onderhoudsprojecten? Dan is deze job zeker iets voor jou!
Voor een grote, internationale speler binnen de Voeding industrie zijn we op zoek naar een Technisch werkvoorbereider. Voel jij jezelf klaar voor deze uitdaging? Wil je samen met Jefferson Wells deze opdracht aangaan? Lees dan zeker verder!
Jouw verantwoordelijkheden?
Als Technisch Werkvoorbereider ben je verantwoordelijk voor het omzetten van geplande technische werkzaamheden in werkinstructies en werk je mee aan continue verbetering van de processen/werking. Jouw verantwoordelijkheden:
Je maakt een inschatting van de nodige tijd, materiaal, mensen en kosten voor de werken
Je geeft de nodige tijd voor de werkzaamheden door aan de werkopvolger
Je voorziet de techniekers van werkinstructies, tekeningen, afregelingsinstructies
Je geeft de nodige wisselstukken/onderdelen door aan de Technisch Inkoper
Je voert risicoanalyses uit en voorziet de nodige persoonlijke beschermingsmiddelen
Je begeleidt externe leveranciers met duidelijke afspraken rond veiligheid, kwaliteit, milieu en duurzaamheid
Je volgt en evalueert de uitgevoerde werken op
Je begeleidt en volgt kleine investeringsprojecten op
Je informeert en overlegt met alle betrokken interne afdelingen
Wie ben je?
Om de rol van Technisch Werkvoorbereider goed in te vullen heb je een Bachelor denkniveau(via diploma en/of ervaring) en heb je al enige ervaring als Technical Planner. Je hebt een goede technische kennis en ervaring met machines/onderdelen in een productieomgeving Daarnaast ben je communicatief en heb je naast jouw administratieve en planmatige skills ookeen hands-on mentaliteit. Je hebt een sterk probleemoplossend denkvermogen en een krak in proactief denken en handelen. Je kan je vlot uitdrukken in het Nederland en Engels.
Ervaring met Ultimo wordt aanzien als een pluspunt!
Wat kan je verwachten?
Als Technisch Werkvoorbereider krijg je een aantrekkelijke 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. Ook freelancers kunnen in aanmerking komen.
Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks of contacteer Sara Van den Bossche op het nummer +32 (0)4 72 79 10 42
Our partner is currently looking for a Quality Ops Partner to join its team. This international company is well-known for its pharmaceuticals.
What are your responsibilities?
You will be part of the Development Quality Pharma Operational team and will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development by :
Driving continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
Providing support to build the end to end “issued copy process’ for DEV/DSC entities.
Acting as Reconciler by checking the correct completion of the “issued Copy” process
Providing support during regulatory inspections, and quality improvement initiatives.
You will contribute the preparation of audits (internal/external, regulatory inspections)
Providing guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
Identify, mitigate and subsequently resolve compliance and quality issues that may affect internal development activities and products.
Supporting QA activities for all Dev QA entities ( Lab, pilot plant,…..)
Maintaining and continuously improving Quality systems and processes in place for the appropriate documentation of internal development activities and ensure compliance with regulatory and corporate requirements.
Implementing and maintaining adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.
Managing Quality meetings to maintain adequate level of compliance of the business activities.
Ensuring data integrity and compliance with regulatory requirements and industry best practices
Proactively support the activities of Development Quality Lead for relevant laboratory/manufacturing quality systems (deviation close out / change management/ complaints/ quality improvement).
Ensuring Development Quality Management System directly support Technical Operations and development partner goals and objectives.
Who are you?
You hold a master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance and quality systems is an asset.
Good written/oral communication in English
Ability to work autonomously for the assigned activities with limited supervision
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations.
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.
Vendor Quality Lead Contracting – Walloon Brabant Our partner is currently looking for a Vendor Quality Lead Drug Product to join its team. This international company is well-known for its pharmaceuticals. What are your responsibilities?
Being the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors.
Performing the QA review of deviation notifications and change controls, retrieving and collecting supportive information from involved stakeholders to allow assessment.
Managing the key performance indicators for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance
Ensuring all Quality agreements are in place and take ownership of agreements for the vendors. Maintaining Quality Agreement with the vendors up to date and performing periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, being sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensuring the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensuring that this review is documented and made available in the Controlled Documents System.
Participating as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Monitor and trend vendor performance including tracking of CAPA events and closure
Quality Complaints: Being the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensuring 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, working with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinating vendor quality related investigations
Participating on ad-hoc basis to the Product Change Control Committees for activities related to the vendors and review change controls as QA stakeholder.
Providing expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Working closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Covering 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
Owning of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensuring all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensuring review of relevant RA dossier section related to the assigned vendors
Having the overview of audit and HA inspections related to the vendors. Tracking and following-up on Audit observation and CAPA plan implementation at the vendor.
Being the QA stakeholder for Vendor Risk management.
Managing and controlling quality documents related to the vendors in the Controlled Documents System
Providing support to customer audits and Health Authority inspections at the vendors, as needed
Receiving, coordinating, reviewing and authorizing product reworks and repackaging
Being the point of contact for post-release vendor quality issues (supply chain, distribution, etc.)
Who are you?
You hold a Master’s degree in scientific domain.
You have an experience within the pharmaceutical industry and in a Quality Assurance role.
You are familiar with aseptic processes.
You have an experience in root cause and risk management/assessment skills.
You have an experience in CMO management.
Knowledge of validation is a plus.
You are knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
You have good background knowledge of the pharmaceutical industry from a business and technical perspective.
You are able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
You speak fluently French and 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.
To help confirming nature of NPL and associated accountabilities and responsibilities under the lead of PVU Supply Chain
To help defining and improving routine process, templates, specifics in managing change controls for NPL under responsibility of Global Planning, together with PVU SC Integration
To orchestrate NPL supply readiness and changes in compliance with internal processes
To execute NPL associated activities per Global Planning ownership
To support Launch Excellence team for compliance to Launch Change control
Lifecycle Management activities
To assess Life cycle management (LCM) requests, support categorization to help defining associated accountabilities and responsibilities under the lead of Product Supply Planning Lead
To define and/or improve routine process, templates, specifics in managing change controls for LCM activities under responsibility of Global Planning, together with GSC Excellence
To orchestrate LCM supply readiness and changes in compliance with internal processes
To execute LCM associated activities per Global Planning ownership
Launch, Coordinate & Track Change control for execution
As part of the Global Supply Chain Community
To behave with discipline by strictly following defined processes, systems and supply governances
To be an ambassador of the company and Global Supply chain values in action
To continuously connect to the team and the community to keep improving business acumen
To embrace changes and ambition in enhancing GSC capabilities
Are you the candidate we're looking for?
Master's Degree
You are fluent in French & in English
8-10 years minimum of experience in Supply Chain operations, Center of Excellence, or associated consulting domains with past proven experience in Tactical Planning activities, Product supply flows activation and New Product Launches in Pharma sector Experience in SAP, SourceCD, TrackWise preferred
Demonstrated E2E Supply Chain Professional Capabilities o Disciplined in critical GxP activities execution
Project management experience
Process and Analytical mindset, KPI and Result Driven
Demonstrated Capability of ensuring E2E visibility and accountability on an entire Supply chain flow
Good understanding of S&OP and Strategic Supply planning processes
Ability to learn fast within a complex environment
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺
We can't wait to meet you, so don't wait any longer!
Vast Contract – Regio Lier #project #manager #projectopvolging
Beschik je over een master industriële wetenschappen? Heb je werkervaring met het opvolgen van projecten in de chemische of petrochemische sector? Heb je een ruime technische kennis en kan je zowel zelfstandig als in team werken? Lees dan vooral verder!
Onze partner is op zoek naar een Project Manager om een projectteam aan te sturen. Dit toonaangevend productiebedrijf gelegen in Lier is wereldwijd actief binnen de petrochemische sector en staat bekend omwille van hun duurzame oplossingen voor hun klanten.
Jouw verantwoordelijkheden?
Als Project Manager kom je terecht in een dynamische en uitdagende omgeving en krijg je de algemene verantwoordelijkheid voor de uitvoering van verschillende projecten. Jouw takenpakket bestaat uit een aantal gevarieerde activiteiten:
Je volgt de planning, ontwikkeling en het budget van het project op.
Je bent het aanspreekpunt voor de onderaannemers, opdrachtgever en andere externe partijen
Je coördineert het project team
Je volgt dagelijkse alle activiteiten op bij realisatie van het project
Je voert controles en inspecties uit on-site en stelt adviezen op om risico’s te vermijden.
Je registreert en meldt interne en externe klachten, afwijkingen en tekortkomingen en neemt hiervoor de nodige maatregelen.
Je grijpt in bij technische problemen en stuurt bij waar nodig
Wie ben je?
Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Project Manager over een master industriële wetenschappen of gelijkwaardig door ervaring aangevuld met een opleiding projectbeheer of een ruime ervaring in projectopvolging. Je bent communicatief vaardig in het Nederlands en Engels. Frans en Duits zijn pluspunten. Daarnaast heb je een proactieve ingesteldheid en heb je organisatorische capaciteiten. Tot slot ben je ook een doelgericht persoon met sterke Analytische skills.
Wat kan je verwachten?
Als Project Manager 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 Jens Blanchet op het nummer +32 (0)4 79 43 32 62 of via jens.blanchet(@)jeffersonwells.be.
Vast Contract – Regio Brugge #quality #engineer #elektromechanica
Beschik je over een master elektromechanica of gelijkwaardig door ervaring? Heb je een grote interesse in alles wat met kwaliteit te maken heeft in de industrie? Weet je wat een Root Cause Analysis is? Lees dan vooral verder! Nog geen ervaring als Quality Engineer? Geen probleem, opleiding word voorzien.
Onze partner is op zoek naar een Quality Engineer om hun kwaliteitsteam te versterken. Dit sterk groeiend productiebedrijf gelegen in Brugge is wereldwijd bekend omwille van hun complexe assemblages voor motoren en aandrijfsystemen.
Jouw verantwoordelijkheden?
Als Quality Engineer kom je terecht in een industriële mechanisch gerichte omgeving en krijg je de verantwoordelijkheid over het opvolgen van de kwaliteit in de productie en van projecten. Jouw takenpakket bestaat uit een aantal gevarieerde activiteiten:
Je volgt de kwaliteitsproblemen op via Root Cause Analyses
Je voert interne audits uit en neemt acties om problemen op te lossen die zich voordoen
Je zorgt ervoor dat de CAPEX projecten voldoen aan de kwaliteitsnormen
Je voert audits uit bij de suppliers en checkt of ze in orde zijn met hun ISO certificaten
Je ondersteunt en volgt de Advanced Product Quality Planning op
Wie ben je?
Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Quality Engineer over een master elektromechanica aangevuld met een grote affiniteit voor kwaliteit. Ervaringbinnen een industriële omgeving is een pluspunt. Je bent communicatief vaardig in het Nederlands en Engels. Daarnaast heb je een proactieve ingesteldheid en ben je administratief sterk. Tot slot ben je ook een communicatief persoon met sterke analytische skills.
Wat kan je verwachten?
Als Quality Engineer 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 Martine Vergote op het nummer +32 (0)4 95 36 51 42 of via martine.vergote(@)jeffersonwells.be.
Purpose of the position Supports the Project Manager in the execution of the project by realizing the mechanical design. Position within the company Reports to the Senior mechanical engineer and the Project Manager. Job brief Your tasks will be: (Mechanical) engineering of installations in accordance with applicable international norms and standards, project requirements and project standards. Ensures that the installation complies with the project specifications. It is important that the candidate has experience with equipment design. Knowledge of Steel Structural design is also an advantage. Responsibilities and duties • Determining material choices • Develop welding procedures in consultation with external welding engineer • Selection and interpretation of applicable norms, codes and standards (international, customer-specific and/or internal) • Mechanical design calculations • Coordination with subcontractors and suppliers • Assistance in the daily follow-up of the activities during the realization of the project. • Monitoring the quality in the execution of the project and during fabrication in particular, by carrying out checks and inspections • Drawing up checklists and purchase lists (mechanical) • Follow-up of the ITP (Inspection and Test Plan) • Assist the safety advisor by drafting task risk analysis and work instructions for site activities • Carry out occasional site inspections for compliance with safety regulations
