Lab Systems Support Specialist Contracting – Antwerp Functieomschrijving: Verantwoordelijk voor operationele ondersteuning, lifecycle management en IT-infrastructuur van gecomputeriseerde labsystemen binnen QC, MSAT en productie, zowel in GMP- als non-GMP-omgevingen. Belangrijkste taken:
Beheren van de volledige lifecycle van labsystemen: ontwerp, implementatie, onderhoud en afbouw.
Ontwikkelen, implementeren en onderhouden van installatieprocedures en architectuurspecificaties.
2e en 3e lijns ondersteuning bieden, inclusief troubleshooting, prestatieanalyse en onderhoud van systemen.
Backup-, herstel- en disaster recovery-plannen opstellen, onderhouden en testen.
Ondersteunen van validatie- en kwalificatieactiviteiten; waarborgen van GMP-compliance en data-integriteit.
Samenwerken met interne stakeholders (QC, MSAT, productie, QA, Validatie) en leveranciers; contacten onderhouden met internationale collega’s.
Documenteren van technische specificaties en kennisdeling binnen IT, QA en Validatie.
Vereiste kwalificaties:
Technische kennis: Windows 10/11, Server 2016/2022, TCP/IP, Active Directory, antivirus, remote administration, scripting (DOS, VBScript, PowerShell).
Ervaring met installatie, troubleshooting en onderhoud van Microsoft-systemen.
Kennis van GMP, GAMP5, CFR 21 Part 11 en validatie/kwalificatie-methodologie.
Nauwkeurig kunnen schrijven van technische specificaties en installatie-instructies.
Sterke communicatieve vaardigheden en servicegerichte houding.
Zelfstandig én in teamverband kunnen werken; initiatief nemen.
Vloeiend in Nederlands en Engels.
Pré-kwalificaties:
Ervaring in een vergelijkbare GMP lab systems support rol.
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? This position will provide leadership and in-depth QA expertise in driving strategic and operational Quality Assurance activities associated with complex Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for the company Products.
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 to 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 (Vendor QA KPI tracker, QuickScore) 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 vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the company Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and 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 company Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed work with the Vendor team and CMC Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the company Product Change Control Committees for activities related to the vendors
Provide in-depth expert QA advice, support and management for technical operational QA and general QA strategic matters associated with the vendors
Work closely with Global 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
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of the company audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging
Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL’s on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
As required provide Operational QA support to other vendors
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Acts as a coach for VQL’s with less experience.
Work in accordance with internal HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process.
Who are you?
Master’s degree in Life Sciences, Engineering, or a related field
Experience in Quality Assurance.
Experience in vendor management.
Experience with Quality Management Systems (QMS) in pharmaceutical manufacturing environments.
Knowledge of aseptic manufacturing processes.
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 work independently and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
Possess good auditing capabilities and skills.
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
Root cause and risk management/assessment 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.
Project Engineer Site Technical Services Contracting – Antwerp
Taken • Bieden van technische en projectmatige ondersteuning om een robuuste farmaceutische productie van Medical Devices en Combination Products (MDCP) te waarborgen. • Ondersteunen van product lifecycle activiteiten zoals productlanceringen, technische onderzoeken, change management en continue verbetering. • Uitvoeren en ondersteunen van technische onderzoeken en probleemoplossing binnen productieprocessen. • Beheren of ondersteunen van technische verbeter- en implementatieprojecten. • Ondersteunen van design- en proceswijzigingen en uitvoeren van bijhorende risicoanalyses. • Zorgen voor naleving van GMP-richtlijnen en interne kwaliteits- en regulatoire vereisten. • Ondersteunen bij het onderzoek van klantklachten en implementeren van corrigerende en preventieve acties (CAPA). • Samenwerken met Manufacturing Quality Assurance bij de behandeling van Non-Conformance Reports (NCR) en de kwalificatie van materialen en processen. • Leiden of ondersteunen van technische projecten inclusief planning, risicoanalyse en uitvoering. • Voorbereiden en onderhouden van technische documentatie zoals protocollen, rapporten en risicoanalyses. • Ondersteunen van productlanceringen, line extensions en marktuitbreidingsactiviteiten. • Coördineren met Operations, Engineering, QA en leveranciers om een tijdige uitvoering van activiteiten te garanderen. • Identificeren van technische risico’s en bijdragen aan continue verbeteringsinitiatieven. • Samenwerken met productie, R&D, Quality en Regulatory Affairs binnen product- en proces lifecycle management.
Profiel • Masterdiploma in Engineering (Mechanisch, Biomedisch, Chemisch, Manufacturing) of gelijkwaardig door ervaring. • Ervaring in farmaceutische of medische hulpmiddelenproductie of technische projectondersteuning is een pluspunt. • Goede kennis van GMP en kwaliteitssystemen. • Sterke analytische vaardigheden en probleemoplossend vermogen. • Goede projectmanagement- en organisatorische vaardigheden. • Sterke communicatieve vaardigheden en teamgerichte houding. • Nauwkeurig, kwaliteits- en veiligheidsgericht. • Vlotte kennis van het Engels, kennis van het Nederlands is een plus.
Nice to have • Kennis van 21 CFR Part 820, ISO 13485 en ISO 14971. • Ervaring met medical devices of combinatieproducten. • Ervaring met injection molding technologieën binnen de medische sector.
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27502
QA Systems Officer Utilities
Contracting – Brabant Wallon
Your responsibilities: General QA Role
Ensure compliance with all relevant regulatory requirements
Organize adequate quality oversight on GMP documentation and activities.
Promote leading and proactive management of deviations, corrective and preventative actions and change controls.
Actively participate to the quality governance in place within the organization.
Ensure appropriate quality indicators are monitored (both leading and lagging) and adhered to.
Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS.
Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections.
Promote strong communication within Quality teams and strive for reducing variability to aim for One Quality Voice.
Foster a culture of quality, compliance, and continuous improvement within the organization.
Beltech Utilities support
Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval.
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.
Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
QA follow-up of utilities/Beltech related projects and project management.
Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used Pharma & Injectable, T2, T4 and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures
Back up fonction
The position can act as back-up for his direct colleagues or for his manager according to the Manager 's instructions and after appropriate training
Your profile:
Master's degree in a relevant field (e.g., Engineering, Science or a related discipline).
Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory
Experience with Quality Management Systems and Auditing is an asset
Fluent in French, very good level in English is required
Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
Team player with good interpersonal relationships and communication 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]
Mission: The Launch Excellence Project Engineering service is responsible for managing validation activities related to the introduction of new products at the manufacturing site. The role ensures that all processes linked to product launch comply with regulatory requirements, internal quality standards, and GMP guidelines throughout the product lifecycle. The service also contributes to project coordination, risk management, and quality investigation activities required for successful product implementation. Key Responsibilities:
Validation Activities
Plan, execute, and document validation activities associated with new product introduction.
Validate processes related to: formulation, filling, shipping, packaging
Ensure validation documentation complies with GMP and regulatory standards.
Execute and document urgent quality investigations.
Analyze deviations, identify root causes, and implement corrective actions.
Ensure traceability and documentation of all investigations.
Conduct risk assessments for processes and systems.
Identify potential risks related to product implementation.
Define and implement risk mitigation strategies.
Support process changes and system updates related to new product introduction.
Collaborate with cross-functional teams to implement improvements.
Coordinate project activities related to product launch.
Plan timelines, deliverables, and project milestones.
Track progress and resolve issues.
Provide project status reporting to stakeholders.
Prepare technical and validation documentation.
Ensure documentation meets regulatory and internal quality requirements.
Maintain organized and auditable project records.
Profile:
Master’s degree in a scientific discipline
Fluency in Dutch & English
Validation processes and documentation
Risk assessment methodologies
Quality investigation and deviation analysis
Knowledge of Good Manufacturing Practices (GMP)
Project planning and coordination
Technical report writing
Work may require flexibility for shift work depending on project needs.
Collaboration with multiple departments (quality, manufacturing, engineering, regulatory).
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]
Writing, reviewing and approving of validation plans and validation summary reports
Reviewing and approving of design documentation (TCD, ERES, URS, DQ, …)
Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
Writing and reviewing of Periodic Review Reports (PR)
Reviewing and approving of CSV specific documentation (inventory, …)
Reviewing of CVS specific SOP’S and Templates
Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerized systems.
Ensure QA activities on quality systems (CAPA, Deviation, Change Control, …) related to automated and computerized systems.
Support team and management during internal and external audits
Your profile:
CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
Certification in computer system validation or equivalent is a plus.
Experience in a computer systems validation role
Experience with SAP, MS Office
Fluency 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]
