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.
Process Engineer Antwerp – Contracting Our partner is looking for a Process Engineer to join its team. This international company is well known for its pharmaceuticals. What are your responsibilities? Process Engineering entails being responsible for technical, operational, compliance, and qualification support for GMP and non-GMP systems within the company’s manufacturing and R&D environments. This encompasses project management and execution of discrete work scopes for overall project delivery, with a strong focus on process design, equipment validation, and continuous improvement.
Provide technical, operational, compliance, and qualification support for GMP and non-GMP systems
Manage and execute discrete project work scopes to support overall project delivery
Support process design, equipment validation, and continuous improvement initiatives
Identify and resolve production bottlenecks
Conduct root cause investigations for quality deviations
Implement changes to existing equipment
Support the introduction and validation of new products and processes
Develop and implement automated visual inspection systems
Manage and support electronic batch records
Support tech transfer activities for vaccine manufacturing processes
Provide support for product validation activities, including follow-up and support of launch projects
Document qualification work in aseptic manufacturing and engineering
Support routine operations in line with established procedures
Who are you?
Master’s degree in industrial, civil, bio-engineering, chemical, or mechanical engineering, or an industrial pharmacist degree
Experience in an engineering, technical, or operations role within a GMP industrial environment
Proven expertise in projects and equipment qualification
Strong analytical and problem-solving skills with a structured approach
Ability to work independently and as part of a team
Excellent written and verbal communication and interpersonal skills
Proficiency in Dutch and English
Experience with process equipment
Knowledge of structured problem-solving methodologies (e.g., FMEA)
Experience with control systems (PLC, SCADA)
Flexibility for shift work or weekend coverage may be required for some projects
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.
Kwalificeren en valideren van analytische methoden en method improvements
Opstellen en uitvoeren van validatie- en kwalificatieprotocollen
Coördineren van laboratoriumactiviteiten en opvolgen van analyses
Interpreteren van resultaten en opstellen van technische rapporten
Faciliteren en uitvoeren van risicoanalyses (Risk Assessments)
Ondersteunen van verificatie- en validatieactiviteiten
Beheren van één of meerdere projecten, inclusief planning en opvolging
Onderzoeken en oplossen van dringende kwaliteitsissues
Implementeren van wijzigingen en introduceren van nieuwe methoden en apparatuur
Ontwikkelen en kwalificeren van computer-gestuurde systemen voor laboratoriumtoepassingen
Fungeren als back-up en kennisdrager voor andere project engineers
De functie vereist het correct interpreteren en toepassen van: GMP-regelgeving (EU, US, …), Internationale richtlijnen en standaarden (zoals ISO, ICH), Interne kwaliteitsstandaarden en procedures
Profiel en kwalificaties
Masterdiploma in industriële wetenschappen, bio-ingenieurswetenschappen, industriële farmacie of gelijkwaardig door ervaring
Of een wetenschappelijke opleiding zoals Bio-ingenieur, Farmaceut, Biochemie of Biotechnologie
Ervaring in een farmaceutische (GMP) laboratorium- of productieomgeving is een sterke troef
Praktische ervaring met method validatie, validatiestrategieën en statistische data-analyse
Sterke analytische vaardigheden en oog voor detail
Uitstekende communicatieve en organisatorische vaardigheden
Ervaring met stakeholdermanagement en technische documentatie
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27237
BMDS Analytical Scientist
Contracting – Brabant Wallon
Your responsibilities: Context The SNC DEV department works on clinical-stage molecules. The team focuses on BMDS / Biological Method Development (bio-methods). Main techniques used in the team:
Contribute to method development and method validation
Work in pairs or small groups (min. 2 people on each validation)
GMP Documentation:
Ensure full compliance with GMP requirements
Complete all associated test documentation
Potentially contribute to drafting protocols and reports (depending on mission duration and autonomy)
Your profile:
Hands-on experience in at least 1–2 of the following techniques: ELISA (binding / potency / HCP), Cell-based assays, qPCR, dPCR
Previous GMP experience
Experience in method development and/or method validation is highly valued
Strong troubleshooting mindset and scientific rigor
Fluency in French & English
Nice-to-Haves
Combined experience in QC and development
Bioanalytical scientist with hands-on experience in key techniques, able to quickly be active in the lab, autonomous on experiments yet collaborative in interpretation and documentation.
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]
In Vitro Laboratory Scientist Brabant Wallon – Contracting Our partner is looking for an In Vitro Laboratory Scientist to join its team. This international company is well known for its pharmaceuticals. What are your responsibilities? As a Laboratory Scientist in the In Vitro Safety team, you will be responsible for designing, planning, and executing a wide range of hands-on laboratory experiments to support the drug discovery and safety assessment projects.
Execute in vitro and histology and wet laboratory-based activities from an experimental point of view
Design and plan experiments, organize and prepare samples, process experimental data, capture findings in reports and communicate with team members and project leads to optimally support project portfolio
Work independently and cross functionally across various teams to tackle scientific problems
Collaborate closely with senior scientists and pathologists to ensure accurate interpretation of in vitro and histological/immunohistochemical data
Ability to work independently, meet tight deadlines, and integrate novel technologies quickly
Present results and findings at internal project teams
Conduct in vitro experiments to identify potential liabilities in pre-clinical drug development
Develop, optimize, and validate IHC assays (e.g., colorimetric, fluorescent)
Design of experimental set-up, sample organization and preparation, data processing and analysis, reporting of the results
Ensure translation of strategy into hands-on lab work
Execute laboratory activities for the development and optimization of innovative methods and in vitro models, enabling biochemical and biological assays to elucidate molecular mechanisms of toxicity.
Ensure that activities are conducted in ethical and safe manner according to the company code of conduct
Guarantee proper experiment planning and execution, providing technical support when necessary
Who are you?
Master in biology, biochemistry, or immunology.
Expertise in mammalian cell culture (primary, iPSC), molecular biology (RNA, DNA, qPCR) and biochemical endpoints (Capillary electrophoresis-based immuno-assay, Western Blot, ELISA, MSD)
Previous experience with the technical steps in histology processing, including tissue trimming, embedding, sectioning, and staining (e.g., H&E, special stains).
Ability to think critically and demonstrated troubleshooting and problem-solving skills (identify problems, collect and analyze data, establish facts, and draw valid conclusions)
Well organized, flexible, meticulous and rigorous with good time management
Good skills in scientific writing and competence in creating reports
Ability to work independently in experimental design, execution, data analysis, data interpretation and communication
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.
Project Engineer Lab Support (Compliance & Validation)
Als Project Engineer Lab Support werk je binnen Lab Operations en ben je mee verantwoordelijk voor de compliance van (bio)analytische methodes en QC-processen in een GMP-omgeving. Je ondersteunt release testing, procesintermediaren, kwaliteitscontrole van afgewerkte producten en stabiliteitsstudies met diverse analytische en bio-analytische technieken (o.a. HPLC, GC, ELISA).
Taken
Methodevalidatie, methodetransfer en implementatie
Bewaken van compendiale compliance en opvolgen van updates
Beheer van QC-kritische processen en QC-projecten
Ondersteuning bij audits en PAT-initiatieven
Projectmanagement, documentatie en stakeholdercommunicatie
Troubleshooting en root cause analysis
Profiel
Master in een wetenschappelijke richting
Min. 1 jaar ervaring in een GMP-omgeving (QC/validatie is een plus)
Kennis van (bio)analytische technieken
Sterk in data-analyse, communicatie en projectmatig werken
Opstellen van elektronische batchrecords (EBR’s) voor de introductie van nieuwe projecten binnen een productieomgeving.
Bewerken en controleren van documentatie om te waarborgen dat alle content voldoet aan hoge kwaliteits- en editorial standaarden.
Configureren van productieprocessen in het MES-systeem (PAS-X).
Vertalen van productieprocessen naar een Master Batch Record (MBR) binnen het MES-systeem.
Samenwerken met projectteams om projectbehoeften te beoordelen en ondersteuning te bieden bij documentatie en communicatie.
Bewaken van consistentie in werkwijzen en documentatie.
Ontwikkelen en implementeren van richtlijnen en standaarden.
Begeleiden van projecten gedurende de volledige levenscyclus: van concept tot implementatie.
Kwalificaties en ervaring
Beschikt over een bacheloropleiding of een gelijkwaardig niveau door relevante werkervaring.
Aantoonbare kennis van MBR-ontwerp in PAS-X of een vergelijkbaar MES-systeem.
Sterke schriftelijke en mondelinge communicatieve vaardigheden in Nederlands en Engels.
Kan zowel zelfstandig als in teamverband werken en beschikt over goede communicatieve en interpersoonlijke vaardigheden.
Werkt gestructureerd en volgens planning.
Vereiste kennis
In staat om procesgerelateerde activiteiten (zoals CIP, SIP, lektesten, media-, buffer- en processtappen) zelfstandig te vertalen naar een Master Batch Record (MBR) in het MES-systeem.
Aanvullende informatie
Hybride werkvorm: 60% op locatie en 40% thuiswerk.
Taalvereiste: vloeiend in spreken en schrijven van Nederlands en Engels.
Relevante ervaring binnen een productieomgeving is vereist.
