Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27302
Vendor Quality Lead
Contracting – Brabant Wallon
Your responsibilities: We are looking for a Vendor Quality Lead to reinforce the R&D & Pharmacovigilance Vendor Quality team. The role is needed to support GCP-focused vendor qualification activities, quality agreements setup, and vendor oversight, especially due to a current backlog of agreements and increasing number of GCP vendors.
Managing GCP vendor qualification activities.
Handling the setup, review, update and closure of Quality Agreements (priority scope).
Proven experience in vendor qualification / vendor management.
Solid experience in Quality Agreements lifecycle management.
Knowledge of regulatory requirements (EMA/FDA/ICH).
Experience with risk‑based oversight and CAPA lifecycle.
Fluent English & French.
Ability to work with digital tools and comfortable with technological processes.
Strong professional judgment, ability to act independently and manage complex situations.
Nice to have
Experience with Digital/IT systems, data integrity, IT validation, eClinical tools.
Legal/paralegal background is an asset for Quality Agreement work.
Experience with AI‑driven or digitalization initiatives.
Vendor management experience in additional GxP areas (but not GMP/GDP profiles).
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]
Ontwikkelen, implementeren en uitvoeren van URS-, SIA-, DQ-, IQ-, OQ-, PQ-, RV- en TM-activiteiten.
Ontwikkelen, implementeren en uitvoeren van validatiestudies voor cGMP-kritische gecomputeriseerde systemen om naleving van cGMP-, gebruikers- en regelgevingseisen aan te tonen. Dit betreft een hands-on rol.
Opstellen van validatiedocumentatie (protocollen en rapporten) en ondersteuning bieden bij de uitvoering van validatieprotocollen voor gecomputeriseerde systemen.
Verantwoordelijk voor validatiedocumentatie tot en met goedkeuring en implementatie.
Uitvoeren van systeemvalidatie waarvoor industriële precedenten bestaan, maar waarbij interpretatie van standaarden nodig is, in overeenstemming met cGMP, cGLP en Sanofi-procedures.
Waarborgen dat de gevalideerde status van gecomputeriseerde systemen te allen tijde voldoet aan cGMP-vereisten.
Zorgen dat projecten worden beheerd volgens alle vereiste Sanofi-standaarden en cGMP-regelgeving.
Op de hoogte blijven van nieuwe validatieregelgeving en testpraktijken om te blijven voldoen aan of te overtreffen aan cGMP-vereisten. Bieden van technische ondersteuning met betrekking tot actuele FDA- (VS) en EU-validatievereisten.
Bijdragen aan de beoordeling van wijzigingen en inschatten of deze impact hebben op de gevalideerde status en bijbehorende validatiedocumentatie.
Onderzoeken en oplossen van validatie-issues en afwijkingen.
Wij zijn op zoek naar een Validation Engineer met projectervaring in de validatie van softwarepakketten en gecomputeriseerde systemen.
Vaardigheden en ervaring
Sterke communicatieve vaardigheden
In staat om zelfstandig te werken en snel nieuwe kennis op te nemen
In staat om projecten volgens planning uit te voeren
Grondige kennis van Computer Systems Validation (CSV)
Volledig begrip van relevante kwaliteits- en compliance-regelgeving
Vaardig in het analyseren en oplossen van validatieproblemen
Minimaal 3 jaar ervaring in de farmaceutische sector en een GMP-omgeving
Goede kennis van zowel Engels als Nederlands
Ervaring met DCS-systemen (Emerson DeltaV) is een pluspunt
Functieomschrijving Als Project Engineer HVAC ben je verantwoordelijk voor de technische opvolging en uitvoering van HVAC-projecten binnen een gereguleerde farmaceutische productieomgeving. De focus ligt op ventilatie, cleanroominstallaties en commissioning-activiteiten. Je werkt hands-on mee in de constructieve fase van het project en fungeert als technisch aanspreekpunt tussen verschillende interne departementen en externe partijen.
Taken en verantwoordelijkheden
Nakijken en beoordelen van technische fiches en documentatie
Actieve betrokkenheid in de constructie- en commissioningfase van HVAC-installaties
Inregelen van luchtkleppen en opvolgen van ventilatieprestaties
Coördineren en opvolgen van installatie, opstart en verificatie van HVAC-systemen
Hands-on ondersteuning op de werf en in productieomgevingen
Communiceren en samenwerken met diverse afdelingen (Engineering, QA, Operations, Contractors)
Sporadisch opstellen en/of aanvullen van technische en validatiedocumentatie
Werken volgens geldende GMP-, veiligheids- en kwaliteitsrichtlijnen
Meewerken aan risicoanalyses en continue verbeteringen
Profiel
Ingenieursdiploma (Industrieel, Burgerlijk of gelijkwaardig door ervaring)
Indien geen specifieke HVAC-opleiding: ingenieursachtergrond is een must
Medior tot senior ervaring in HVAC of technische projectengineering
Sterke hands-on mentaliteit en proactieve werkhouding
Goede kennis van ventilatietechnieken
Kennis van F-gassen is een sterke meerwaarde
Ervaring in een gereguleerde omgeving (bij voorkeur farmaceutisch, GMP)
Sterke communicatieve vaardigheden en vlot in samenwerking met verschillende stakeholders
Zelfstandig kunnen werken, maar ook teamgericht
Goede organisatorische vaardigheden en het vermogen om prioriteiten te stellen
Talen
Nederlands: zeer goed
Engels: zeer goed
Extra troeven
Ervaring met commissioning van HVAC-installaties
Kennis van GMP, risicomanagement (bv. FMEA)
Ervaring met CAPEX-projecten en projectcoördinatie
Project Validation Coordinator Antwerp – Contracting Our partner is looking for a Project Validation Coordinator to join its team. This international company is well known for its pharmaceuticals. The Project Validation Coordinator (VALCO) supports the project lead in coordinating the project team to achieve defined project deliverables related to validation, as well as the overall project timeline. What are your responsibilities?
Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management and inspectors.
Continuously follows up the predefined validation strategy, adjusts and/or escalates if needed and provides overview of the status and potential impact on project timeline.
Coaches the project engineers related to validation and quality systems and watches over good validation practices and the quality of the different deliverables.
Facilitates and documents quality system risk assessment activities.
Provides input for management communication & reporting.
Bridges between Engineering, Quality Projects, STS/LA, SME’s and System Owners.
Functions as subteamlead Validation within the project team charter
Supports the project lead in coordinating the project team to achieve the defined project time line.
Composes, consolidates and maintains the general project schedule file to keep the overview of all milestones towards the completion of the project
Monitors continuously this overall project schedule file and keeps the project team informed regarding the progress and alerts problems/conflicts relating to the execution of project tasks and interrelations of project activities
Assists the project lead to define and evaluate planning risks and mitigation plan.
Provides input for management communication & reporting.
Who are you?
Master’s degree is commonly required, typically in industrial, civil, or bio-engineering, or industrial pharmacy, or a scientific field such as biochemistry or biotechnology
Perfect command of Dutch and good knowledge of English (written and oral) is required
Experience in a GMP environment is consistently desired or required
Background in project coordination, validation, and quality systems.
Experience working in cross-functional project teams.
Strong organizational and planning skills.
Ability to coordinate multiple stakeholders and bridge between technical and quality functions.
Good communication skills for interaction with project teams, management, and inspectors.
Proactive, structured, and able to follow up on strategy, planning, and risks.
What can you expect? 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.
Laboratory Operations Project Engineer Antwerp – Contracting Our partner is looking for a Lab Operations Project Engineer to join its team. This international company is well known for its pharmaceuticals. Lab Operations Project Engineering entails being responsible for the compliance assessment of method validation and compendial compliance dossiers. This service involves the careful implementation of new test methods and procedures in Quality Control Operations, including coordinating and planning project activities.
What are your responsibilities?
Implementation of new test methods and procedures in Quality Control Operations
Coordination and planning of project activities
Writing and reviewing protocols, testing scripts, and reports
Management of deviations
Review of validation and transfer test results
Validation of necessary files (e.g., SoftMaxPro, Excel)
Verification of compendial tests
Support of QC analysts during test execution
Troubleshooting for issues encountered during testing
Performing root cause analysis using methods such as DMAIC
Co-authoring submissions for new medicines/vaccines
Efficient and thorough investigation of analytical deviations
Determination of root causes and initiation of corrective and preventive actions to address quality-related deficiencies
Execution of strategic initiatives
Resolution of complex issues
Development of innovative solutions
Guidance of technical direction
Coordination of other resources and facilitation of knowledge transfer within service parameters
Who are you?
Master’s degree is commonly required, typically in industrial, civil, or bio-engineering, or industrial pharmacy, or a scientific field such as biochemistry or biotechnology
Perfect command of Dutch and good knowledge of English (written and oral) is required
Strong communication skills (written and oral)
Strong organizational skills and accuracy
Strong technical writing ability
Analytical skills and problem-solving abilities
Experience in a GMP environment is required
Team player with strong interpersonal skills
What can you expect? 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.
Ability to handle pushback, challenge stakeholders, and defend QA standards with solid arguments.
Excellent communication & coordination skills.
Ability to work autonomously, analyze data, and make decisions.
Good comprehension of regulatory/CMC requirements.
Nice to have:
Experience in Data Integrity (mindset more important than hands‑on reporting).
Experience in GMP audits & inspections.
Project management skills.
Background in production/manufacturing to better understand operational partners.
Knowledge of biologics + small molecules (products can be pharma or bio).
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]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27277
ELN Business Analyst & Developer
Contracting – Brabant Wallon
Your responsibilities:
Business Analysis: conduct stakeholder interviews, process mapping, and current state assessments across CMC Dev laboratories to translate & align needs into clear requirements or user stories, and testing scripts / criteria.
ELN template Design & Development: Apply established processes & style guide to design and configure ELN experiment templates, forms, calculation sheets, workflows, approval steps, audit trails, etc.
ELN structured data structuration: Configure data mapping according to CMC data models ensuring data/metadata schemas are aligned to FAIR principles and scientific and industry domain standards
Optimize usability and search/discovery/re-usability (naming conventions, taxonomies, tagging, template reuse, Inventory), & integration with other computerized systems
Ensure fit for purpose of Digital Operations solutions, and solution & business readiness for implementation – further support change management by monitoring the adoption and performance of newly implemented solutions
Deliver process and solutions documentation, datasets and trainings
Contribute to solutions lifecycle with change requests, impact assessment and continuous improvement
Your profile:
Hands-on expertise configuring and developing within IDBS E‑WorkBook (on premise or Cloud) or similar ELN solution
Hand-on experience and strong understanding of CMC Development laboratory workflows (small molecules, biologics, analytical development, sample & inventory management)
Business Analysis & Product Skills with demonstrated proactiveness, curiosity, analytical and self-reliant mindset
Knowledge of regulatory requirements and quality standards in the biopharmaceutical industry is a plus
Excellent communication, interpersonal and facilitation skills
Continuous improvement and customer-centric thinking, but balanced with an ability to challenge legacy landscape
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]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27275
Qualified Person
Contracting – Brabant Wallon
Your responsibilities: A typical day involves hands‑on operational QA/QP work, including:
Batch release & certification of APIs, excipients, primary packaging, bulk products (tablets & injectables), and final packaged products.
Market complaint handling.
Managing deviations, investigations, CAPAs, recalls, change controls, retests, rework/reprocess, and approval of PQRs/LQRs.
Interacting daily with production teams on the shopfloor (no makeup/jewelry allowed in production areas).
Reviewing and approving procedures in the QP activity scope.
Supporting internal audits, client audits, and inspections.
Ensuring products meet GMP standards and regulatory/MA dossier requirements.
Being reactive to production needs while also having the authority to block batches when needed.
Your profile:
Ideally 5 years relevant experience
Belgian Qualified Person (QP) number – mandatory and non‑negotiable.
Industrial pharmacist degree.
Operational mindset: enjoys being on the shopfloor and reacting swiftly to production realities.
Strong French communication skills (native or fully fluent) + good English for interactions with global teams.
Ability to work under pressure and remain supportive yet firm, especially when blocking non‑compliant batches.
Strong team spirit, collaborative attitude, ease of contact with multiple departments.
Willingness to learn, follow procedures, apply GMP, and avoid taking risks beyond their level of expertise.
Nice to have:
Previous experience in GMP/QP activities, QA, Production or QC.
Experience in packaging operations.
A personality that adapts well, avoids conflict, and fits a collaborative culture.
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]
Jouw verantwoordelijkheden? De Batch Doc reviewer is verantwoordelijk voor het kwalitatief, nauwkeurig,efficiënt, volgens instructies en binnen de correcte aflevertijd nakijken van batchdocumentatie voor klinische studiemedicatie.
• Als batch doc reviewer in de verpakkingsafdeling zal je ingezet wordenin dagshift. • Je kijkt na dat alle interventies en handelingen, uitgevoerd door operatoren zijngedocumenteerd in de batch documenten. Hierna worden deze batchdocumenten ter review aangeboden aan QA. • Indien nodig, zal je mee ingezet worden om eventuele afwijkingen teonderzoeken, opvolgen en te documenteren in het Trackwise systeem. • Je helpt mee met de klachtenbehandeling van interne en externe partijen. • Alle activiteiten dienen volgens SOP en GMP richtlijnen uitgevoerd te worden.
Wie ben je? • Kennis van cGMP • In staat om praktijkgericht te denken in kader van kwaliteit & veiligheid. • Flexibel met een gevoel van urgentie. • Een goede team player met gepaste communicatie en in staat om metverschillende profielen en afdelingen samen te werken (e.g.planning, QA, batchdoc&label group, teamleads, operators,engineering and technical services.) • Bij voorkeur heb je ervaring met klinische verpakking en structuren • Zeer grondige kennis van GMP en goede documentatie richtlijnen • Professionele kennis inzake veiligheid, hygiëne en milieureglementeringen • Je bent gebonden aan vastgelegde processen en procedures • Je doet beroep op de leidinggevende bij escalatie van problemen
Wat kan je verwachten? Je komt terecht in een internationale en innovatieve werkomgeving waar veiligheid, kwaliteit en samenwerking centraal staan. Je ontvangt een competitief loonpakket en uitgebreide extralegale voordelen, met volop kansen om je technische kennis verder te ontwikkelen en bij te dragen aan uitdagende projecten.
Quality Project Associate Antwerp – Contracting Our partner is looking for a Quality Project Associate to join its team. This international company is well known for its pharmaceuticals. What are your responsibilities? The Quality Project Associating services focus on quality oversight and project support, delivering essential quality oversight and comprehensive project support for pharmaceutical processes and products within the company Belgian sites, specifically the aseptic manufacturing plant. Provide technical, operational, compliance, and qualification support for GMP and non-GMP systems
Provide quality oversight and comprehensive project support for pharmaceutical processes and products
Act as an independent quality authority for product-related qualifications and validations
Ensure regulatory CMC compliance of plant processes with regulatory filings
Contribute to compliant and right first-time product launches
Perform quality reviews of validation documentation, change records, and procedures
Coordinate regulatory submissions
Support Quality Management Systems, including validation, Quality Risk Management (QRM), and change management
Conduct end-to-end validations of new products (formulation, filling, and packaging)
Prepare validation documentation
Monitor production batches
Analyze validation results
Perform root cause investigations for deviations and propose corrective and preventive actions
Support the creation and maintenance of Master Batch Records
Actively contribute to continuous improvement initiatives
Who are you?
Master’s degree in a relevant scientific or engineering discipline (Industrial Engineering, Civil Engineering, Bio-engineering, (Industrial) Pharmacy) or equivalent experience in Biochemistry or Biotechnology
Know-how of project management within the pharmaceutical or related industries
Strong experience in GMP-regulated and aseptic environments
Strong analytical and problem-solving skills
Excellent organizational skills
Meticulous, accurate, and quality-conscious work approach
Strong communication, interpersonal, and technical writing skills
Ability to collaborate effectively with cross-functional teams and external stakeholders
Perfect command of Dutch and good knowledge of English (written and oral)
What can you expect? 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.
