Your responsibilities: Commissioning and Qualification: Review IQOQ protocols and reports to ensure the qualification of CPP, support the team for risk analysis creation (SRA), review equivalence certificate, write validation plans…
Validation: According to the client’s standards and procedures, design the validation strategy through PQ protocol redaction, ensure the readiness for PQ validation, coordinate validation (on the floor job expected), manage unplanned events associated with validation, be the contact with QC.
Product validation: Understand the product validation lifecycle and ensure that the validation strategy is in line with the product validation strategy, support the product steward in product related topic (E&L, holding time, …).
Change Control: Assessment of the validation impact through eCC assessment (Stakeholder role expected), Coordinate eCC, and be responsible of eCC tasks.
Project management: Plan and manage PQ activities (material, documentation, people…), support the project planner, animation of meetings/workshops, help the production representative in the understanding of validation requirements.
Your profile:
University degree (Biotechnology, Agronomy, Chemistry or Pharmacy).
At least 5 years’ professional experience in pharmaceutical environment, in quality and validation environment.
Good oral and written communication skills in French & English (for efficient communication with engineering office and suppliers).
Good Knowledge of GMP Regulated environment related to validation activities.
Good interpersonal relationship skills – To be a good team player to success in each validation.
Problem solving and achievement oriented.
Be organized.
Nice to have:
Knowledge of freezer dryers, filling lines and isolators would be an asset.
To maintain and keep up to date its knowledge and experience necessary to the function.
Ability to take decisions in stressful conditions.
Proactive and ready to take the lead to make things happen.
Ability to work under pressure on multiple deliverables within project timelines.
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. Are you interested in this job? I kindly invite you to apply or send me your CV, [email protected]
Product Quality as the independent quality authority for product-related qualifications and validations of the assigned products.
Compliant and right first-time product launches within Quality Operations (QO)
Regulatory CMC (= Chemistry, Manufacturing & Controls) compliance of the plant processes with the regulatory filings
Validation Act as quality authority in a consistent way, in compliance with cGMPs and current regulatory expectations, for the following qualification and validation documents:
Process qualification/validation
Method validation
Filter validation
Component qualification
Raw material evaluation
DHF
Registration The composition, production processes, specifications, analytical methods of the drug products are described in the registration dossiers of the different markets. The QPA is responsible for pursuing regulatory CMC compliance of the site practice versus the registration dossiers. This is achieved by participating in the following processes:
Data verification and QA review of initial marketing authorization filings and variations, responses to health authority queries, briefing documents for scientific advice meetings;
Performing compliance checks of the registration dossiers of the different markets versus the site practice.
Implementation Ensure correct and timely implementation of approved regulatory changes in the site: follow-up on approvals and commitments in the different markets.
Your profile:
Master’s degree in scientific discipline
2 years of relevant experience in the pharmaceutical sector and/or medical device industry with specific experience or interest in Quality Assurance or Compliance and in regulatory affairs (CMC) for pharmaceutical products.
Quality mindset
Pragmatic
Excellent analytical and problem-solving skills
Excellent oral and written communication skills and social skills
Scientific knowledge and skills
Languages: fluent in Dutch and English
Excellent knowledge of cGMP, regulatory guidances and relevant medical device and combination product regulations.
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. Are you interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Ontwikkelen, implementeren en uitvoeren van URS, SIA, DQ, IQ, OQ, PQ, RV en TM activiteiten voor kleinschalige apparatuur, inclusief de bijhorende software.
Opzetten en uitvoeren van validatiestudies voor cGMP-kritische processystemen om compliance met cGMP, gebruikers- en regelgevingsvereisten aan te tonen.
Uitvoeren van kwalificaties van systemen waar industriestandaarden bestaan maar interpretatie vereist is, conform cGMP, cGLP’s en Sanofi-procedures.
Zorgen dat de gekwalificeerde status van systemen steeds cGMP-conform blijft.
Ondersteunen van projecten in lijn met cGMP-regelgevingsnormen.
Op de hoogte blijven van nieuwe validatieregels en testpraktijken, en technische ondersteuning bieden m.b.t. FDA- en EU-vereisten.
Beheren van validatiedocumentatie van opmaak tot goedkeuring en implementatie.
Input leveren bij change assessments om te bepalen of wijzigingen impact hebben op de gekwalificeerde status en documentatie.
Profiel
Grondige kennis van cGMP-vereisten in een gereguleerde omgeving.
Begrip van relevante kwaliteits- en compliance-regelgeving.
Probleemoplossend en in staat om validatie-issues te troubleshooten.
Goede kennis van Quality Management Systems.
Ervaring: 2–4 jaar in een farmaceutische of healthcare productieomgeving, met specifieke ervaring in kwalificatie van kleinschalige apparatuur en bijhorende software.
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]
Ondersteunen van de QA Engineering afdeling bij alle Qualification/Validation activiteiten gedurende de volledige levenscyclus van systemen en processen (concept, project, operationeel, retirefase).
Reviewen en goedkeuren van kwalificatie- en validatiedocumenten, SOP’s, user requirements, risicoanalyses, testplannen, test scripts, change controls, CAPA’s, etc., conform cGMP.
Actief deelnemen aan engineering teams en samenwerking met andere groepen bij introductie of upgrade van systemen en processen.
Adviseren en ondersteunen bij voorbereiding en uitvoering van kwalificatie-/validatieactiviteiten en bewaken van cGMP compliance.
Opvolgen en afhandelen van afwijkingen tijdens kwalificatie-/validatieactiviteiten.
Rapporteren van status (kwaliteit, compliance, planning) aan QA Qualification/Validation team.
Profiel
Ervaring in chemische of farmaceutische industrie op het vlak van qualification/validation.
Kennis van cGMP regelgeving en richtlijnen.
Vermogen om technische informatie te vertalen naar begrijpbare informatie voor alle niveaus.
In staat om urgentie, kritischheid en impact van beslissingen correct in te schatten.
Multitasken en werken aan meerdere projecten tegelijkertijd.
Zelfstandig werken én functioneren in cross-functionele teams.
Sterke communicatieve vaardigheden.
Vloeiend in Nederlands en Engels (mondeling en schriftelijk).
Kennis van systemen binnen pharma/chemical sector: Manufacturing, Lab, Building, Utility, IT, Automation.
Ervaring met probleemrapportering, change requests en document management systemen (bv. Trackwise, Comet, TruVault) en test tools zoals Kneat.
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]
Job Title: Agile Project Lead – Security & Infrastructure
Location: Brussels area (hybrid) Sector: Insurance
Role Overview
Role Overview
For one of our partners in the banking sector, we are looking for an Agile Project Lead – Security & Infrastructure to join the IT Foundations team within the IT4IT department. This role is key to driving strategic infrastructure initiatives, with a strong focus on IT security and risk management.
If you combine an analytical mindset with strong coordination skills and the ambition to lead end-to-end delivery of high-impact projects, this could be the right opportunity for you.
Key Responsibilities
Business & IT Alignment
Work with experts to document user journeys and IT processes.
Translate IT–business requirements into EPICs and clear, actionable specifications.
Ensure IT needs are consistently converted into tangible business value.
Project Planning & Delivery
Define and manage project plans including scope, budget, planning, and risk analysis.
Align plans with sponsors and stakeholders.
Foster seamless collaboration between business and IT within the Agile framework.
Execution & Coordination
Identify and coordinate the involvement of delivery teams.
Ensure progress and delivery of commitments in close collaboration with Product Owners, Chief Product Owners, and internal/external stakeholders.
Oversee timely delivery of outputs by all teams involved.
Stakeholder Engagement & Leadership
Act as a central contact point for initiatives, maintaining transparent communication.
Build trustful, long-term relationships with both internal and external stakeholders.
Anticipate challenges, escalate when necessary, and remove delivery obstacles.
Motivate stakeholders and teams to maintain a solution-oriented and collaborative mindset.
Evaluation & Continuous Improvement
Track progress using key indicators (lead/lag metrics).
Capture lessons learned and integrate improvements for future projects.
Actively contribute to refining governance processes and best practices.
Strategic & Complex Initiatives
Lead projects with high business impact across multiple departments and partners.
Ensure strategic alignment, governance compliance, and proactive risk mitigation.
Contribute to continuous improvement of initiative management within the organization.
Profile
Strong affinity with IT infrastructure, risk management, and IT security.
Proven experience managing agile projects and coordinating cross-functional teams.
Excellent communication, negotiation, and coordination skills with a pragmatic, results-driven mindset.
Skilled in stakeholder management with the ability to engage at both operational and executive levels.
Structured approach to handling complex, large-scale initiatives.
Fluent in Dutch or French, with good proficiency in the second national language and English.
We are looking for a Project Manager to strengthen our team in the Brussels area. The ideal candidate has solid experience in managing projects, strong communication skills, and the ability to work effectively in an international and multilingual environment.
You will be responsible for managing projects from initiation to closure, coordinating with stakeholders, ensuring timely delivery, and maintaining alignment with business goals. Agile methodologies are central to our way of working, and certification in Agile/PM (Scrum Master, Prince2, PMP, or equivalent) is considered a strong asset.
Key Responsibilities
Lead and manage projects from initiation to delivery, ensuring scope, budget, and timelines are respected.
Apply Agile project management methodologies and foster collaboration across teams.
Facilitate communication and alignment between stakeholders, business units, and technical teams.
Monitor risks, issues, and dependencies, and propose corrective actions when needed.
Ensure clear project documentation and reporting.
Profile
Languages: Fluent in one of the local languages (French or Dutch) with a good understanding of the other. Good knowledge in English.
Methodology: Solid experience with Agile frameworks; certification is a strong plus.
Skills: Strong communication, stakeholder management, and problem-solving skills.
Location: Based in Brussels or nearby, with flexibility for hybrid work.
Technische expertise in inspectieapparatuur en -technologieën (visuele inspectiemachines, leak testers, camera- en sensorsystemen, reject handling, automatisering).
Opstellen en documenteren van technische specificaties (EDS, P&ID’s, elektrische schema’s) en afstemmen met SME’s.
Werken volgens engineeringstandaarden en afstemmen met de Lead Engineer tijdens ontwerp, constructie en implementatie.
Opvolgen van constructie, installatie en inbedrijfstelling om te garanderen dat de installatie voldoet aan de specificaties.
Toepassen van projectmanagementtools (planning, budget, risico’s, rapportering, stakeholderbeheer).
Aansturen en opvolgen van contractors voor bouw, installatie en testen van de inspectieapparatuur.
Verantwoordelijk voor overdracht naar operations, inclusief volledige projectdocumentatie en projectafsluiting.
Opvolgen van opstartresultaten om te verzekeren dat de projectdoelstellingen behaald zijn.
Documenteren van constructie, verificatie en validatie in het engineering projectdossier.
Definiëren en uitvoeren van engineeringtesten, verificatie en validatie van inspectieapparatuur.
Opstellen van validatieaanpak, testprotocollen, verificatie- en validatiedocumenten.
Uitvoeren van testen en coördineren van goedkeuringen door SME’s en systeemverantwoordelijken.
Beheren en documenteren van afwijkingen en acties (CAPA’s, risicoanalyses, cGMP-review, document updates).
Profiel
Master/Bachelor in engineering of gelijkwaardig door ervaring.
Ervaring met inspectieapparatuur in farmaceutische productie is een pluspunt.
Kennis van testen, verificatie en validatie van systemen (ervaring in steriele omgeving is een plus).
Goede kennis van cGMP en compliancevereisten.
Communicatieve vaardigheden in Nederlands en Engels.
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]
