Functie omschrijving Je bent verantwoordelijk voor het zelfstandig uitvoeren en rapporteren van één of meerdere routinematige chemische testen, om aan te tonen dat PGS Puurs voldoet aan de wettelijke en geldende cGMP richtlijnen voor o.a. aseptisch bereide farmaceutische producten. Na een opleidingsperiode voer je zelfstandig labo-analyses uit (non-chromatografische en/of chromatografische testen). Deze analyses worden uitgevoerd ter ondersteuning van productrelease. Je zorgt ervoor dat de documentatie van uitgevoerde analyses correct is en conform cGPM/GLP richtlijnen. Je zorgt ervoor dat jouw kennis over cGMP/GLP, procedures en veiligheid up-to-date blijft.
Profiel
Je beschikt bij voorkeur over een professionele bachelor in farmaceutische wetenschappen, chemie, farmaceutische of biologische laboratorium technologie.
Je werkt nauwgezet en draagt kwaliteit hoog in het vaandel.
Je hebt een hoog probleemoplossend vermogen.
Je vindt veiligheid zeer belangrijk.
Je bent flexibel en hebt een “can-do” mentaliteit.
Je beschikt over een goede kennis van Nederlands en Engels.
Je kan werken met PC software applicaties (MS Office, LIMS).
Relevante ervaring in een GMP omgeving is een pluspunt.
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27581
Knowledge Management Expert
Contracting – Brabant Wallon
Your responsibilities: The Knowledge Management Expert plays a key role in ensuring that the Quality Management System (QMS) remains fully aligned with applicable GxP regulations and that critical knowledge is efficiently captured, structured, and shared across the Quality organization. The role is responsible for mapping regulatory requirements to internal QMS policies and procedures, developing and maintaining a repository of regulations and regulatory intelligence, overseeing compliant implementation within the QMS, and enabling the effective flow of actionable knowledge across Quality.
Regulatory Mapping & Compliance Alignment
Systematically map global and regional GxP regulations, guidelines, and standards to internal Quality policies, processes, and procedures.
Identify gaps, overlaps, and misalignments between regulations and internal documentation; collaborate with QMS Process Owners to drive remediation.
Ensure traceability between regulatory requirements and QMS documents through structured mapping tools or frameworks.
Monitor changes in relevant regulations and proactively evaluate their impact on the QMS.
Regulatory Repository Ownership
Build, maintain, and continuously update a centralized repository of all applicable regulations and guidelines (e.g., EU, FDA, ICH, PIC/S, EMA, local authorities).
Establish governance for regulatory document lifecycle, version control, and archiving.
Provide Quality teams with timely access to the most current regulatory information and insights.
QMS Oversight & Implementation Monitoring
Maintain oversight of how regulatory requirements are embedded across the GxP QMS.
Develop and track KPIs or dashboards that measure the completeness and accuracy of regulatory implementation.
Support internal audits, inspections, and assessments by providing clear regulatory mapping and QMS insights.
Partner with Quality Systems, Compliance, and Process Owners to ensure adherence to evolving regulatory expectations.
Knowledge Sharing & Organizational Learning
Design and implement strategies, processes, and tools to support the effective flow of Quality knowledge across functions.
Develop user-friendly summaries, guidance documents, and knowledge assets to promote understanding of regulatory expectations.
Facilitate communities of practice, learning sessions, and cross-functional knowledge exchanges.
Promote a culture of knowledge stewardship and continuous learning within Quality, eventually expanding these capabilities to wider functions.
Your profile:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or related field.
Strong experience in GxP Quality Assurance, Quality Systems, Regulatory Affairs, or related domain.
Solid understanding of global pharmaceutical regulations (e.g., EMA, FDA, ICH).
Experience with QMS frameworks and documentation systems.
Fluency in French & English.
Nice to have
Background in knowledge management, information architecture, or process excellence.
Experience with digital knowledge tools (e.g., regulatory intelligence databases, document repositories, QMS platforms).
Familiarity with change management and effective communication strategies.
You will support the development and delivery of ADA immunogenicity assays and associated data sets in support of our biologics (NBE) and/or gene therapy pipeline.
Work within the bioanalytical teams to optimize experimental design, sample analysis, data interpretation and report generation.
Have an opportunity to support the delivery of other bioanalytical methods including, such as cell-based assays.
Your profile:
At least a BSc in a biological discipline with 1 year of hands-on experience in Bioanalysis.
Experience in developing and validating assays to assess immunogenicity.
Demonstrate in-depth technical understanding of ligand binding assays, particularly on platforms like MSD (Gyrolab, ELISA), dealing with complex ADA assays.
Experience with assessing and/or overcoming Drug, Target interference, presence of Pre-existing ADA, characterization of multi-domain specificity in immunogenicity assays.
Ensure adherence to quality standards while supporting the delivery of assays and critical data sets within project deadlines.
Ability to generate, analyze, interpret, and present critical data sets.
An ability to work in a matrix and communicate clearly.
Be agile and flexible in adapting to changing projects and organizational priorities, aligned with project deadlines and departmental needs.
Global Paper archivist Governance Lead & Process Data Owner
Contracting – Brabant Wallon
Your responsibilities: The company is creating a new global role to take full ownership of paper archiving governance across all sites and affiliates. Although a global paper archiving process already exists, its local implementation has not been consistently followed or monitored, leading to gaps, risks, and deviations. The objective is to harmonize, structure, and operationalize paper archiving practices globally, ensure inspection readiness, and reduce regulatory, data privacy, and operational risks. The role will also act as Process Data Owner, the paper archiving system already live in several countries and being extended further.
Interacting with global and local stakeholders to understand how paper archiving is implemented at site level.
Assessing gaps based on existing assessments and defining practical action plans.
Building and animating a community/network of archivists.
Supporting and governing the Doxis system (validation status, access, data structure, user support).
Reviewing and aligning retention schedules, procedures, and documentation.
Managing topics related to external archiving vendors (governance, access, quality agreements).
Preparing for inspections, managing deviations and CAPAs, and driving continuous improvement initiatives.
The role requires autonomy, initiative, and a “helicopter view” of global archiving activities.
Your profile:
Minimum 5 years of experience in records management or archiving within a regulated environment, with enough experience to work independently and proactively without close daily supervision.
Solid experience in paper archiving / records management.
Experience in a regulated environment (preferably pharmaceutical or healthcare).
Strong understanding of data integrity principles (ALCOA+).
Strong communication skills and ability to work within a global network.
Comfortable working in English and French.
Strong organizational and stakeholder management skills.
Soft skills (initiative, autonomy, communication, project mindset) will be a key evaluation criterion.
Nice to have:
Knowledge of GxP environments and differences between manufacturing, non-clinical, etc.
Experience with document management or archiving systems.
Project Engineer in Sterilization Validation Vast contract – Antwerpen
Jouw verantwoordelijkheden?
Als sterilisatie validatie project ingenieur ben je verantwoordelijk voor het uitwerken van de validatie strategie, het coördineren, inplannen en uitvoeren/opvolgen van de validatie studie/testen en het interpreteren en documenteren van de testresultaten. Dit alles bundel je in een validatie protocol en rapport welke tijdig opgeleverd en goedgekeurd wordt tegen de afgesproken due date
Bij afwijkende resultaten voert de project ingenieur een root cause analyse uit (M1 methodologie, Human Error analyse), waarbij de problemen en impact in kaart worden gebracht, alsook mogelijke oplossingen onderzocht worden. Indien nodig dient een deviatie/notificatie opgesteld te worden.
Na uitvoeren van een project wordt van de project ingenieur verwacht om de sterilisatie validatie werkdocumenten zoals herkwalificatie controlled forms, procedures en rationales tijdig en correct up te daten en/of uit te geven en ook door te trainen, indien nodig.
Als project ingenieur ben je verantwoordelijk voor het beantwoorden van technische sterilisatie validatie gerelateerde vragen.
Je speelt een sleutelrol bij audits. Je werkt mee aan audit voorbereiding, waarbij je documentatie reviewt. Tijdens de audit zelf kan je voor bepaalde vragen als spokes person optreden en/of een rol spelen bij het voorbereiden van een vraag.
Als project ingenieur ben je verantwoordelijk voor de review van jaarlijkse herkwalificatie studies binnen je kennisdomein. Hierbij ben je verantwoordelijk voor het analyseren van de testresultaten en goedkeuren van de herkwalificatie documentatie.
Je werkt aan efficiëntie, optimalisatie en innovatieve projecten, je zorgt voor ‘continuous improvement’ binnen het team en voert deze uit overeenkomstig met cGMP, internal en wettelijke standaarden.
Wie ben je?
Master opleiding in een wetenschappelijke richting (Bio ingenieur, Apotheker, Biochemie of Biotechnologie) of gelijkwaardig door ervaring.
Perfecte beheersing van het Nederlands.
Goede kennis van het Engels (schriftelijk en mondeling).
Sterke interpersoonlijke vaardigheden, team player.
Communicatief sterk.
Je werkt georganiseerd, accuraat en kwaliteitsbewust.
Analytische vaardigheden en probleemoplossend vermogen.
Goede technische schrijfstijl.
Onderlegd in prioriteit-setting.
Flexibiliteit in werkuren: Je werkt in dagregime maar sporadisch kan shift- of weekendwerk gevraagd worden.
Gezonde interesse in technologie (meetapparatuur, software, …).
Ervaring en/of kennis van sterilisatieprocessen en/of validatie.
Ervaring in een vergelijkbare functie, kwaliteits- of productieomgeving.
Ervaring in een GMP omgeving.
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.
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.
De rol van Project Engineer is een uitdagende job waarbij je veel kennis opbouwt over verschillende productieprocessen en systemen en waarbij je de kans krijgt om de high level wettelijke vereisten te vertalen in een praktisch uitvoerbare en aanvaardbare approach. Deze functie biedt veel variatie en interactie met verschillende afdelingen zoals productie, engineering, QA, ECO en site compliance.
Als Project Engineer sta je in voor volgende taken:
Je voert validatieprojecten uit van aanpassingen aan bestaande processen
Je onderhoudt het media fill systeem en voert vernieuwingen en verbeteringen door
Je bent aanspreekpunt voor andere afdelingen als expert in de validatie van aseptische vulprocessen
Wie ben je?
Bij voorkeur heb je een masteropleiding in een wetenschappelijke richting gevolgd
Je hebt kennis van aseptische productie en affiniteit met productiesystemen
Je bent sterk in analytisch denken en prioriteiten stellen
Je kan ordelijk en gestructureerd werken
Je bent een teamplayer met een positieve attitude
Kennis van aseptische kwaliteitssystemen is een nice-to-have
Kennis in project management en microbiologie is een troef
Perfecte beheersing van het Nederlands en het Engels
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.
Your responsibilities: Part of the Internal Bio & GT manufacturing Systems Quality Team, you will:
Work closely with Clinical Manufacturing Teams to ensure 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.
Ensure adequate QA support for environmental monitoring, qualification, validation (including cleaning) and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas
Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect development activities and products.
Support Change Control, Deviation, Events, Investigations,… and perform the QA evaluation
Ensure KPI (including extracts) are adequately maintained and Shared.
Ensure Issued Copy document are following the issued copy and reconciliation process
Your profile:
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 manufacturing, facility operation, laboratory compliance and quality systems is essential.
Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
Understands practical applications of GMP, compliance principles and theories including risk management
Fluency in French & English
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
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]
Your responsibilities: As a TST Portfolio Manager, you will use robust project/portfolio management and communication skills to set-up, structure & coordinate the CMC projects portfolio in line with the Assets & Patient Supply strategic plans for (a) given compound(s), managing the inter-connections across projects, ensure coordinated plannings & deliverables, the CMC resource allocation to projects, projects prioritization scenarios, budget, financial 10 years plan & tracking of actuals. This function implies close relationships within the technical teams, with Global Regulatory Affairs function within the Patient Evidence, Global Quality and Operational functions to ensure alignment with EU, US, JP & IM teams’ expectations. You are agile, structured, good team player, assertive, enthusiastic and with a positive mindset. As the TST Portfolio Manager, your main activities and roles & responsibilities will be the below:
Provide support and coaching to project managers for creating a master plan for their assigned project that includes timelines, required resources, the order of needed tasks, and the responsibilities of each project team member; the record and tracking of this information in the software applications
Work closely with the project managers to ensure that project milestones are met efficiently and within prescribed budget & resource constraints. Generate monthly reports on schedule adherence.
Consolidate all relevant CMC projects into a Portfolio per compound, ensuring appropriate links between projects, milestones and resources. Develop dashboard and KPI’s to drive efficiently the product portfolio inside the TST.
Identify any resource constraints proactively and drive the prioritization-making process in Patient Supply and CMC: prepare (and present) prioritization proposals to the Patient Supply LT or Asset LT for endorsement after TST agreement/discussion.
Coordinate budgeting effort to align Units, Operations, Functions and Practices to achieve consolidated product projects, budgets and monitoring.
Drive the increase of maturity on project management skills inside TST’s and identify areas of improvement for the CMC community.
Coordinate activities and knowledge gathering to ensure issues are addressed and escalated timely across the product portfolio stakeholders, with assertiveness and deep understanding of SME’s constraints on project/portfolio.
Your profile:
Minimum 5 years of project, program and/or portfolio management experience and in associated tools
Experience in enterprise planning/resource capability and systems. Knowledge of Planisware PPM tool is a strong asset
Solid understanding of the end-to-end CMC/Development (and associated disciplines) is a strong asset.
Languages: English & French
Robust knowledge of change management
A certification in PMP, PRINCE2, Agile, Lean or equivalent is a plus
Knowledge of the pharmaceutical environment; launch and life cycle management processes and the regulations applicable during development is an asset
Your responsibilities: The Precision Medecine (PM) Department is positioned within the function of Translational Science, a division which provides strategy and support to transition novel pharmacological assets, including small-molecule, biologics and gene therapy derived assets, from research into the clinic. PM operate and collaborate closely across the organization to support bioanalysis and biomarker activities. About the role: We are seeking a self‑motivated, lab‑based scientist to support the development of LC‑MS pharmacokinetic assays that will advance our NCE and NBE assets. The lab works in close partnership with the relevant therapeutic area(s). The scientist will also play a pivotal role in transfer of assays into the regulated environment. The individual will also have an opportunity to take on project related responsibilities, executing on tailored bioanalytical strategies. Who you’ll work with: Development Bioanalysis is a team that sits within PM and are responsible for multiple key activities, supporting non-regulatory PK, Biodistribution & Immunogenicity assessments for NCE, NBE and Gene Therapy assets whilst also developing bioanalytical methods to support regulatory studies, transferring these methods into the Regulatory team for subsequent validation and testing. You will operate in a matrix environment, collaborating with a wide range of internal stakeholders including Therapeutic Area project teams, Drug Metabolism and Pharmacokinetics, Non‑Clinical Safety and Quantitative Clinical Pharmacology. What you’ll do:
You will support the development and delivery of LC-MS PK assays and associated data sets for our small-molecule (NCE) and biologics (NBE) pipeline.
Work within the bioanalytical teams to optimize experimental design, sample analysis, data interpretation and report generation.
Your profile:
Candidates should have at least a BSc in a biological discipline with 1-3 years of hands-on experience in Bioanalysis.
Experience with a range of analytical techniques supporting small‑ and large‑molecule bioanalysis, including enzymatic digestion approaches and immunocapture purification.
Biological sample extraction and preparation techniques.
Experience with cell-based and LBA assays is a plus.
Proven track record of providing consistent routine high-quality bioanalytical support.
Assay characterization and acceptance criteria, such as those required for progression of
compounds into development.
Continual bioanalytical method development and optimization.
Trouble shooting of analytical and equipment issues to avoid delays in data generation.
Good judgement to assess fit-for-purpose bioanalytical assay performance.
Expert in LC-MS and other analytical tools, ideally Sciex and Waters LC-MS/MS.
Excellent working knowledge of analytical software packages (Analyst, Sciex OS, Masslynx and Waters Connect).
Demonstrated knowledge in using ELN (Watson, E-Workbook) and Microsoft Office
