Your responsibilities: The incumbent will provide support to the QA operational team in production building by:
Being present in the production area to conduct gembas, housekeeping, and oversight.
Providing support in managing the QA Ops technician team
Reviewing and approving documentation as a quality partner, or provide support during reviews.
Your profile:
A university certificate with scientific orientation (Bio engineer, Biology, Biotechnology, Pharmacology,…) or equivalent experience.
Good knowledge of English (oral and written) & fluent in French
3 years’ experience in cGMP environment
Knowledge of regulatory matters and Good Manufacturing Practices (GMP).
Analytical and critical mind, global and pragmatic approach, problem solving.
Good impact and influence skills as well as networking skills to efficiently work within different Vaccine departments.
Good technical writing 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]
De aandacht voor Data Integrity (DI) groeit explosief, en bevat een prominente rol in audits. DI is allang geen lijstje ALCOA-regels meer – het is uitgegroeid tot een cruciale kwaliteitsmotor die continu evolueert.
Snel ownership nemen over eigen projecten ter ondersteuning van de Local Process Owner Data Integrity.
Verschillende projecten trekken die gericht zijn op het verbeteren of uitrollen van processen die voor de volledige site van toepassing zijn.
Samenwerken met diverse afdelingen (computerized systems, productie, quality, maintenance, …).
Een breed en veelzijdig intern netwerk opbouwen.
Zorgen voor een tijdige, kwalitatieve en budgetconforme oplevering van projecten.
Zowel zelfstandig als in team effectief werken, afhankelijk van de projectnoden.
Kwalificaties Opleiding en/of Ervaring
Master opleiding
Perfecte beheersing van het Nederlands en het Engels
Kennis van productie- en labo-processen en equipment en/of van computer systemen
Ervaring in een GMP omgeving
Een eerste ervaring met Data Integrity is een mooie plus, maar geen vereiste.
Ervaring of sterke interesse in projectgebonden werk. Je weet in projecten en processen een goede balans te vinden tussen compliance en efficiëntie
Vlot overweg met verschillende digitale applicaties en MS office
Communiceert helder en respectvol, zowel mondeling als schriftelijk / gesprekspartner
De consulent beschikt over voldoende geduld en strategisch inzicht om afdeling overschrijdende projecten tot een goed eind te brengen
De consulent werkt gestructureerd en met oog voor detail: bewaakt overzicht, stelt prioriteiten en levert steeds nauwkeurig en betrouwbaar werk af
Vertrouwd om projectplanningen op te stellen, te presenteren en te volgen.
Het succesvol coördineren en uitvoeren van projecten van begin tot eind
Ons aanbod
Jefferson Wells biedt je een vast contract als consultant met een aantrekkelijk salarispakket en toegang tot opleidingen, zowel technisch als op het vlak van soft skills. Wij worden jouw carrièrepartner en begeleiden je bij elke stap in je professionele groei. Ben je geïnteresseerd in deze functie? Dan nodigen we je graag uit om te solliciteren of je cv te sturen naar [email protected].
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#26971
QC Specialist
Contracting – Brabant Wallon
Your responsibilities: The recruitment is to support a complex issue related to PEG, in collaboration with a QC specialist. The work involves technical investigations on polymers, with connections between current analyses, methods, and validations.
Follow-up on deviations and quality issues related to PEG.
Analyze and understand unusual results.
Collaborate with regulatory specs, analytical development, method redesigns, transfers, and production.
Participate in quality committees on Tuesdays and Thursdays.
Use analytical techniques (HPLC, GC, IR, NMR) and software tools (Empower, Cromeleon).
Proactivity, autonomy, ability to raise issues and suggest solutions.
Strong skills in organic and analytical chemistry (HPLC, GC).
Fluent in French and proficient in English (for international meetings).
Understanding of production processes and their analytical impact.
Master’s degree or technician with 5+ years of experience.
Nice to Have:
Familiarity with the lab and internal techniques.
Experience handling quality deviations.
Knowledge of Empower or Cromeleon.
Additional skills in IR, NMR.
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#26936
Internal Operations Quality Partner
Contracting – Brabant Wallon
Your responsibilities: The role is within the Clinical Supply Quality team, focusing on packaging and labeling for clinical studies. The position is critical for ensuring quality systems and compliance in the production, release, and distribution of Investigational Medicinal Products (IMPs) for clinical trials.
– Review of batch records (both electronic and paper). – Review and release of labels. – Release of warehouses and production consumables specification. – Update of CEC (Controlled Environment Conditions). – System-related activities: deviation review, CAPA (Corrective and Preventive Actions), change control. – Temperature excursion management. – Validation activities related to computer design systems. – Documentation review for operational production activities. – KPI realization based on specific requests. – Participation in audits, regulatory inspections, and vendor management. – Support for qualification, validation, and maintenance of equipment and facilities.
Your profile: – 3 to 5 years of relevant experience required. – Pharmaceutical experience is essential; QA/compliance experience in a pharmaceutical regulated environment. – Proficiency in Excel (KPI creation, pivot tables). – Hands-on operational QA experience is important and will make a difference. – Good knowledge of cGMP and relevant regulatory requirements (e.g., US, European, Japanese). – Technical affinity (e.g., point of contact for equipment validation). – Dynamic, energetic, and communicative personality, able to challenge and express opinions. – Fluency in English and French. – Preferably a Master’s degree in engineering or similar for the right mindset. – Ability to function with minimal supervision, strong organizational and analytical skills. – Fact-based decision-making and problem-solving skills (failure investigations, risk analysis).
—- No QP (Qualified Person) number required, but QP training is a plus.
Nice to Have: – Certified auditor by official authorities. – Eligibility to act as a QP in the EU. – Experience in leading internal audits/self-inspections. – Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing, and Controls) 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]
Vendor Quality Lead – QP Contracting – Walloon Brabant
Our partner is currently looking for a VendorQuality Lead to join its team. This international company is well-known for its pharmaceuticals.
What are your responsibilities? In this position, you will support the Qualified Person (QP) in relation to all batch release activity for Global products produced by third parties, primarily performing QA review of batch documents, issue of batch certificates, and transactional release activities.
Vendor Quality Lead (VQL) related accountabilities:
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 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 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 CMC Quality Leads 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 internal 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 internal 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.
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.
Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors.
Qualified Person related accountabilities:
Support the QP in relation to all batch release activity, primarily performing QA review of batch documents.
Issue batch certificates for product release and distribution
Perform in SAP the transactional product release and maintenance of batch release register
Liaise with Vendor Team(s) and CMO’s where applicable on resolution of issues relating to document errors to support release.
Act as QA contact (in conjunction with site QP) and deputize on behalf of QP where appropriate for product related quality issues and associated communications.
Act as a contact with other departments and Affiliates to support the drug product /Finished goods release process and supply of post release documents.
Maintain and report Metrics relating to batch release activities.
Support Global Regulatory Affairs and CMC Quality Leads for submission document requests
Coordinate legalization/notarization of documents as needed
Who are you?
Eligibility as a Qualified Person in EU
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.
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Be capable of leading and motivating teams and demonstrate professional maturity in 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.
De Batch Record Reviewer is verantwoordelijk voor het voorbereiden, controleren en finaliseren van batchrecords. Je maakt deel uit van het Batch Record Review Team, een divers team dat batches voorbereidt en beoordeelt binnen de verschillende productie-eenheden. Nauwe samenwerking met Operations en Quality over de afdelingen heen is essentieel voor deze rol.
Belangrijkste Taken en Verantwoordelijkheden
Uitgebreide review van productie- en reinigingsbatchdocumentatie.
Opstellen van batchtrends voor elke productie- en reinigingsbatch en controleren op volledigheid en eventuele afwijkingen.
Aanvullen van batchdocumentatie met noodzakelijke bijlagen (bijv. eLIMS-resultaten).
Controleren van volledig en correct grondstofverbruik.
Verifiëren, registreren en opvolgen van afwijkingen binnen elke batchrecord.
Correct classificeren van afwijkingen volgens procedures en, indien nodig, initiëren van non-conformiteiten.
Archiveren van batchrecords conform de kwaliteitsrichtlijnen.
Voorbereiden en structureren van batchdocumentatie.
Kwalificaties
Opleiding en/of Ervaring
Je kunt documentatie nauwkeurig en punctueel beoordelen.
Je werkt gestructureerd en kunt effectief prioriteiten stellen.
Je beschikt over sterke communicatievaardigheden.
Je spreekt en leest vloeiend Nederlands.
Ons aanbod Jefferson Wells biedt je een vast contract als consultant met een aantrekkelijk salarispakket en toegang tot opleidingen, zowel technisch als op het vlak van soft skills. Wij worden jouw carrièrepartner en begeleiden je bij elke stap in je professionele groei. Ben je geïnteresseerd in deze functie? Dan nodigen we je graag uit om te solliciteren of je cv te sturen naar [email protected].
Coördineren en plannen van analytische methodeoverdrachten en validaties voor de introductie van nieuwe producten.
Beoordelen van de conformiteit van validatie- en compendiale dossiers.
Implementeren van nieuwe analytische methoden in de QC-operaties in nauwe samenwerking met Analytical R&D.
Opstellen en beoordelen van validatieprotocollen, testscripts, overdrachtsrapporten en afwijkingsrapporten.
Valideren van analytische rekentools (zoals Excel, SoftMaxPro, enz.).
Opleiden en ondersteunen van QC-analisten bij de uitvoering van analysemethoden.
Problemen analyseren en oplossen met behulp van gestructureerde methodieken (DMAIC, root cause analysis).
Mede-auteur zijn van documenten voor regelgevende indieningen (zoals BLA, CTD).
Zorgen voor gegevensintegriteit en GMP-naleving bij alle activiteiten.
Jouw profiel
Bachelor- of masterdiploma in de chemie, biochemie, farmaceutische wetenschappen of een verwant domein.
Ervaring in de farmaceutische sector.
Minstens 1 jaar ervaring in een GMP Quality Control laboratorium (validatie, methodeoverdracht, change control, enz.).
Expertise in analytische technieken zoals HPLC/UPLC, CE, ELISA, qPCR, SDS-PAGE, FACS, enz.
Grondige kennis van methodevalidatie, overdrachtsprocessen en compendiale methoden.
Vaardig in statistische data-analyse en wetenschappelijk schrijven.
Proactief, nauwkeurig en een gestructureerde probleemoplosser.
Vloeiend in het Nederlands en het 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
Quality System Contractor Brabant Wallon – Contracting
What are your responsibilities?
Support and prepare for regulatory inspections and audits.
Lead or assist in Quality Council and Risk Management Committee activities.
Develop and maintain internal audit and self-inspection programs.
Structure and align local documentation with global standards.
Implement and lead local Quality System Reviews.
Promote quality culture and regulatory awareness among staff.
Act as a mentor/coach for quality and regulatory requirements.
Benchmark industry trends and support local/global quality initiatives.
Who are you?
Minimum 8–10 years of experience required in pharmaceutical quality systems.
Pharmaceutical industry experience.
Demonstrated experience in quality systems and compliance.
Experience in audits and inspections.
Ability to work autonomously and proactively.
Fluent in French and English.
Strong interpersonal skills; not afraid to reach out and follow up with colleagues.
Nice to have:
Experience with biological drug substance (business and/or quality).
Agility to handle unpredictable changes and a stressful environment.
Experience collaborating and influencing across departments.
Additional certifications in quality or regulatory affairs.
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 invite you to apply!
Prepare samples, process data, write reports, and present results.
Collaborate with the team to share instruments and knowledge.
Your profile:
Experience in mass spectrometry (high-resolution LCMS).
Skills in analytical method development.
Autonomous work style and ability to manage own schedule.
Good English proficiency (for meetings and international interactions).
Understanding and respect for GMP rules.
Ability to interpret complex spectra, especially for polymers and biomolecules.
Nice to Have:
Experience with polymers and large molecules.
Knowledge of biomolecules (proteins, antibodies).
Experience in a GMP environment.
Willingness to collaborate and support teammates.
Familiarity with various mass spectrometry instruments.
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]
Uitvoeren van validatiestudies en testen in het kader van routine herkwalificaties en kwalificaties van nieuwe sterilisatiesystemen.
Testen uitvoeren volgens testscripts opgesteld door de betrokken projectingenieur.
Verwerken, evalueren en rapporteren van testresultaten volgens GMP-richtlijnen.
Coördineren of zelf uitvoeren van onderzoeken bij afwijkende of niet-conforme resultaten.
Actualiseren van GMP-documentatie (protocollen, rapporten, procedures) na uitvoering van de studies.
Opleiden en ondersteunen van nieuwe teamleden binnen het validatieteam.
Waken over veiligheid, kwaliteit en naleving tijdens alle validatieactiviteiten.
Profiel
Bachelor in een wetenschappelijke richting (chemie, biotechnologie, farmaceutische technologie, …) of gelijkwaardig door ervaring.
Ervaring binnen een GMP-omgeving en/of met validatieprocessen is een pluspunt.
Perfecte kennis van het Nederlands en een goede kennis van het Engels (schriftelijk en mondeling).
Analytisch en probleemoplossend vermogen met oog voor detail.
Sterke communicatieve vaardigheden en een echte teamspeler.
Technisch inzicht en interesse in technologie (meetapparatuur, software, automatisering, …).
Goede technische schrijfstijl en nauwkeurige manier van werken.
In staat om prioriteiten te stellen en zelfstandig te werken.
Veiligheids- en kwaliteitsbewust.
Bereid om te werken in een tweeploegenstelsel (6u–14u en 14u–22u).
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]
