Beheren van validatieactiviteiten voor de introductie van nieuwe producten op de productiesite.
Zorgen dat processen voldoen aan regelgeving en kwaliteitsnormen.
Ondersteunen en documenteren van validatie van belangrijke productieprocessen: formulatie, vullen, verpakking, transport en distributie.
Uitvoeren van kwaliteitsonderzoeken bij problemen, oorzaken identificeren en oplossingen voorstellen.
Uitvoeren van risicoanalyses voor processen en productlanceringen en mitigatiemaatregelen definiëren.
Ondersteunen van proces- en systeemveranderingen bij nieuwe productintroducties en bijwerken van procedures om compliance te waarborgen.
Coördineren van validatieprojecten door activiteiten te plannen, teams te coördineren, voortgang te volgen, problemen op te lossen en statusrapporten op te stellen.
Voorbereiden van technische en validatiedocumentatie conform GMP- en regelgevingseisen.
Dagelijkse activiteiten kunnen zijn:
Schrijven of beoordelen van validatieprotocollen en rapporten.
Deelnemen aan projectvergaderingen.
Uitvoeren van risicoanalyses.
Onderzoeken van kwaliteitsafwijkingen.
Coördineren met engineering-, kwaliteits- en productieteams.
Functieomschrijving Als Project Engineer binnen het projectteam van het microbiologisch laboratorium ben je verantwoordelijk voor de verificatie en implementatie van microbiologische testmethoden voor nieuwe producten. Je speelt een cruciale rol bij het waarborgen dat testmethoden voldoen aan de huidige wetgeving, cGMP-normen en interne kwaliteitsstandaarden. Kernverantwoordelijkheden
Voorbereiden en opstellen van verificatieprotocollen voor microbiologische testmethoden.
Plannen van verificatietests in samenwerking met het operations-team van het laboratorium.
Opvolgen van verificatiemonsters en tests om tijdige uitvoering te garanderen.
Documenteren van verificatieresultaten in rapporten.
Initiëren, beschrijven en opvolgen van afwijkingen die zich voordoen tijdens tests.
Zorgen dat testmethoden voldoen aan de huidige wetgeving, cGMP en interne kwaliteitsstandaarden.
Profiel Vereisten:
Masterdiploma in een wetenschappelijke richting (bijv. bio-ingenieurswetenschappen, biomedische wetenschappen, biochemie of gelijkwaardig).
Bij voorkeur ervaring in aseptische farmaceutische productie of een microbiologisch laboratorium; recent afgestudeerden zijn ook welkom.
Pragmatische aanpak met een sterke drang om oplossingen te vinden en resultaten te behalen.
Uitstekende communicatieve vaardigheden en het vermogen om collega’s op verschillende niveaus te motiveren en inspireren.
Sterke technische schrijfvaardigheden voor documentatie en rapportage.
Vloeiend in Nederlands en Engels.
Vermogen om werk efficiënt te organiseren in een omgeving met veranderende prioriteiten.
Analytische ingesteldheid en oog voor detail.
Wat wij bieden:
Werken in een dynamische, wetenschapsgedreven omgeving bij een toonaangevend farmaceutisch of life sciences-bedrijf.
Betrokkenheid bij innovatieve projecten in microbiologie en productontwikkeling.
Mogelijkheden voor professionele groei en carrièreontwikkeling.
The position can act as back-up for his direct colleagues after appropriate training
OPERATIONAL QA ROLE
Assure that intermediates and active pharmaceuticals products get produced and released in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
Follow up of product related: change control, failure investigation, deviations, CAPA and action plans, qualification of dedicated equipment (protocols and reports)
Review of batch record from intermediates to drug substance
Batch disposition of chemical intermediates (DS manufacturing)
Review of master batch records and specifications
CONTINUOUS IMPROVEMENT
Support the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations
Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the site.
Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projects
Promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BPM and related supporting services
Ensure general cGMP training of internal customers
Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements
Ensure communication of compliance status and issues to appropriate levels of the organization
Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BPM and related supporting services
Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections
Your profile:
Min 3 years experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health related field
Experience with Chemical/ pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industry
Experience with Quality Management System
Ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision
Excellent team player attitude with excellent interpersonal relationship and communication skills
Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
Fluent in French and English
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: The Project Lead will contribute to the company main project “Batch Release digitalization and Electronic Batch record implementation including exception-based release” Project. through:
Defining projects objectives and road map
Guiding and supervising the activities and schedule of the projects to ensure each aspect is complete and accurate
Developing projects plans and presenting scope, solutions to manager
Coordinating, motivating, and leading a matrix team for the successful delivery of assigned projects involving cross-functional colleagues, and other stakeholders.
Managing and escalating projects risks and issues
Process mapping
Support Electronic Batch record roll out across sites with implementation of exception-based review.
Prepare the Selection and proll out exception-based release digital solution
Preparation of business case for one button digital release solution
Your profile:
Quality generalist, with a minimum of 5 years working in the pharmaceutical/biologics industry in a process improvement position or releasing/batch record review function.
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 have a process improvement mindset, able to influence different stakeholders, find common ground and bring stakeholders closer together with aligned approach.
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 possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally, especially at senior management levels.
Be able to coach/train/mentor colleagues and deliver training within area of expertise
Holding a Qualified Person registration number is an asset.
Fluent in English & French
Experience with electronic batch record review is required
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#27448
Documentation Management Expert
Contracting – Brabant Wallon
Your responsibilities: Role Purpose The Documentation Management Expert (QMS Transformation) plays a key role in a cross‑functional program aimed at the end‑to‑end transformation of the Quality Management System (QMS). The role is responsible for designing the future‑state QMS documentation architecture, including document hierarchy, metadata model, lifecycle processes (including translation), and governance, ensuring alignment with GxP regulations, industry standards, and internal quality strategy. This position operates in a project context, focusing on definition, design, and standardization, and provides the foundation for future implementation within electronic document management systems (EDMS). Key Responsibilities
QMS Documentation & Hierarchy Design
Define the future-state document hierarchy for all QMS procedural documents, including Governance & Procedures, Quality Manual, Policies, SOPs and SOP-Ais, Standards and User Guides-A
Establish clear document categories, relationships, and dependencies across the QMS.
Ensure alignment between the document hierarchy and ICH Q10, GxP, ISO standards, and internal quality governance principles.
Metadata Model & Document Taxonomy
Design and document a standardized metadata framework for QMS procedural documents, including : Naming conventions, Versioning rules, Classification attributes, Ownership and governance fields
Define metadata requirements to support: Searchability and usability, Regulatory traceability, Reporting and KPIs, EDMS configuration and automation
Collaborate with Quality Systems and IT to ensure metadata design is system-ready.
Document Lifecycle & Translation Process Design
Define end-to-end lifecycle processes for QMS procedural documents, including: Creation and drafting, Review and approval, Distribution and effective use, Periodic review and revision, Archival and obsolescence
Design and document translation workflows, including: Trigger points for translation, Language scope and prioritization, Roles involved in translation review and approval, Version alignment between source and translated documents
Ensure lifecycle processes are inspection-ready and auditable.
Roles, Responsibilities & Governance (RACI)
Define and document clear roles and responsibilities for all stakeholders involved in QMS procedures, including: Authors, Reviewers, Approvers, Document owners, Quality governance bodies, Translation contributors
Develop RACI models for different document types (Policy, Quality Manual, SOP, SOP-AI, Standard, User Guide).
Ensure consistency of responsibilities across functions and geographies.
Process Design, Alignment & Continuous Improvement
Lead workshops and working sessions to: Assess current-state documentation practices, Identify gaps and inconsistencies, Align stakeholders on future-state standards
Translate project outputs into clear, usable process documentation and guidance.
Define success criteria and KPIs to measure the effectiveness of the future documentation framework.
System Readiness & Implementation Support
Provide business and functional requirements to support implementation of the future-state model in EDMS (e.g. Veeva Vault).
Support validation, user role definition, and data integrity considerations linked to the new documentation framework.
Ensure design decisions support scalability, automation, and long-term sustainability.
Change Management & Enablement
Develop guidance materials, templates, and standards to support adoption of the new QMS documentation framework.
Support communication and training strategies for impacted stakeholders.
Act as a subject-matter expert and advisor throughout the transformation program.
Your profile: Experience, Skills and Knowledge
Strong knowledge of GxP, ICH Q10, ISO 9001, and regulatory requirements related to documentation and data integrity.
Experience with document control processes and QMS frameworks in the pharmaceutical or biotech industry.
Hands-on experience with EDMS platforms (e.g., Veeva Vault)
Solid understanding of document lifecycle management, version control, and procedural governance.
Proven ability to design, optimize, and govern quality processes.
Used to Microsoft 365 suite.
Education & Background
Master’s degree in Sciences, Pharmacy, or a related field.
3–7 years of experience in documentation management, quality systems, or related quality roles in the pharmaceutical industry.
Fluent in French & English
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]
Project Engineer Medical Devices Antwerpen – contracting
Your responsibilities?
Provide technical, scientific and project-driven support to ensure robust pharmaceutical manufacturing within Site Technical Services (STS) MDCP.
Lead and/or support technical improvements, problem solving and the execution of implementation projects, fully aligned with GMP and internal quality systems.
Sustain on-market Medical Device and Combination Products (MDCP) through product/process change and risk management activities as Technical Leader.
Act as production site and R&D facing role.
Facilitate product launch.
Lead post-market changes.
Identify opportunities for continuous improvement.
Support investigations of delivery system customer complaints to determine root cause and implement appropriate corrective preventive actions.
Support Manufacturing Quality Assurance in the disposition of Non-Conforming Reports, qualification of material / processes / changes to assure reliability requirements are met.
Lead or support project management activities including scoping, planning, risk assessments and execution of improvement or investment projects.
Drive process and system improvements (lean/continuous improvement) with a focus on Design History File (DHF) enhancements / updates for specific device presentation / platform.
Prepare, execute and document changes with a focus on design changes, process changes and risk management updates; perform impact assessments and required (re)qualification.
Develop and maintain technical documentation (protocols, reports, work instructions, risk analyses).
Coordinate with Operations, QA, Engineering and suppliers; ensure clear communication and on-time delivery.
Identify, communicate, develop mitigation strategies for technical risks with key stakeholders per appropriate escalation threshold.
Promote and comply with EHS guidelines; integrate safety requirements in designs and changes.
Your profile?
Engineering degree (Bio-engineering or Industrial Engineering preferred)
Project Engineer with experience
Able to work independently from the start
Autonomous and practical mindset
Strong project engineering fundamentals
GMP knowledge is a plus
Strong plus (not mandatory):
Design control
Medical device regulations
Product design in MedTech
Injection techniques related to MedTech
Risk assessment and control strategy in MedTech
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.
The Laboratory Technician will be responsible for the routine production of micro-organisms and the execution of quality control (QC) analyses in accordance with established procedures and production schedules. The role requires strong technical expertise in microbiological techniques, strict adherence to safety and quality standards, and effective collaboration within a multidisciplinary team environment.
Key Responsibilities
Perform and document routine production of micro-organisms in compliance with approved procedures and planning.
Execute and document quality control analyses according to established protocols.
Accurately collect, record, and review production data to ensure batch-to-batch consistency.
Identify, report, and escalate deviations or atypical results to the appropriate supervisor in a timely manner.
Ensure that test procedures and product specifications are correctly applied to support efficient manufacturing operations, on-time product release, and compliance with internal and external requirements.
Maintain high standards of laboratory safety, cleanliness, and organization in accordance with company policies and regulatory guidelines.
Contribute actively to team objectives and support cross-functional collaboration.
Qualifications & Skills
Associate’s or Bachelor’s degree in Microbiology, Biology, or a related scientific discipline.
Proven hands-on experience in handling, culturing, and working with micro-organisms.
Strong understanding of microbiological techniques and laboratory best practices.
High level of accuracy and attention to detail.
Strong organizational and documentation skills.
Team-oriented mindset with the ability to thrive in a collaborative environment.
Good verbal and written communication skills in English; knowledge of Dutch is considered an asset.
Our Offer Jefferson Wells offers you a permanent contract as a consultant with a competitive salary package and provides access to training programs, both in technical subjects and soft skills. We will be your career partner at every step of your professional journey. If you’re interested in this role, please contact adela.amzert @jeffersonwells.be
Your responsibilities: The Scientist will join the Advanced Material Characterization and Investigations (AMCI) group within the Analytical Development (AD) department. AMCI is an international and diverse team of scientists performing advanced analytical characterization of pharmaceutical products and leading global analytical investigations for the commercial product portfolio and for the Discovery, Product Development & Supply (DPDS) organization of R&D. Within AMCI, the Advanced Molecular Analysis (AMA) team is a group of analytical centers of excellence in structure elucidation (by high-resolution mass spectrometry and NMR), organic and inorganic trace analysis, polymer characterization, and ADC, oligonucleotide & peptide analytics. We are currently recruiting a skilled and enthusiastic Chemist to join our AMA team, where you will play a crucial role in our mission to quantify nitrosamines in various matrices and pharmaceutical products. This laboratory-based position offers you the opportunity to develop and implement innovative analytical test methods for nitrosamines, utilizing your strong background in chemistry and mass spectrometry. In this role, you will also collaborate closely with internal specialists to conduct thorough root cause investigations and explore innovative approaches for optimal analyses. If you are passionate about pushing the boundaries of analytical techniques and eager to make a significant impact in the field, we would love to hear from you! Key Responsibilities:
Design and develop advanced analytical methods, from innovative sample preparations to cutting-edge chromatographic separations and detection, for the quantification of nitrosamines, in accordance with regulatory guidelines and company standards.
Support comprehensive root cause investigations related to nitrosamines, with a focus on chemical reactivity, from the early stages through to late development within our R&D portfolio.
Collaborate closely with cross-functional teams, demonstrating your ability to learn rapidly and explore innovative techniques.
Initiate and lead partnerships with universities and other research institutions to expand our external innovation network, fostering collaboration that enhances our capabilities and expertise.
Maintain a safe work environment in compliance with all applicable environmental, health, regulatory requirements, GMP and safety regulations.
Your profile: Education & Experience:
A PhD degree in analytical or organic chemistry, or related field; or a master’s degree in a related science with a minimum of 6 years of experience. Work-related experience in pharmaceutical R&D is an asset.
Proven expertise in nitrosamines determination in pharmaceutical products is a clear asset for this role.
Demonstrated experience in mass spectrometry, including technologies such as Triple Quadrupole and High-Resolution MS, is a significant advantage.
Familiarity with developing chromatographic methods is preferred.
Knowledge of regulatory frameworks (e.g., ICH, EMA, FDA) and GMP guidelines, particularly concerning validation requirements, is an advantage.
Excellent English communication skills, both written and spoken, allowing for effective scientific discussions and collaboration
Competencies:
Fast learner with scientific curiosity, self-steering, pro-active, creative.
Open-minded, with ability to work together as one team in a global environment.
Good written and spoken communication and presentation skills in English.
Efficient, flexible, dynamic, results and performance driven.
Sense of urgency.
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]
