Amstelveen
3 weeks ago
Senior Quality Affairs Officer
Viatris
Amstelveen
3 weeks ago
Senior Quality Affairs Officer
Viatris is seeking a Senior Quality Affairs Officer in Amstelveen, Netherlands, to act as QP and RP and manage quality systems including CAPAs, changes, complaints, and audits. Requires at least 5 years of Pharmaceutical Affairs experience with thorough GMP/GDP knowledge, Dutch native language, and excellent English.
HybridFull-timeMid LevelGMPGDP
Senior Quality Affairs Officer
Viatris is seeking a Senior Quality Affairs Officer in Amstelveen, Netherlands, to act as QP and RP and manage quality systems including CAPAs, changes, complaints, and audits. Requires at least 5 years of Pharmaceutical Affairs experience with thorough GMP/GDP knowledge, Dutch native language, and excellent English.
HybridFull-timeMid LevelGMP
Salary
Not specified
Core Qualifications
Technical (Must-have)
GMPGDPCAPAPMSIsPQRsTechnical AgreementsSupplier qualificationSOPsWIsDutch Medicines ActEU GMP/GDP legislationAuditsInspections
Soft Skills
Highly motivatedAbility to work under pressurePrioritizationCreative problem solvingAdaptabilityTeam playerPeople skillsCollaborationCommunicationAutonomy
Key Responsibilities
- Undertake the role of QP and RP in line with the European and Dutch legal requirements for pharmaceutical manufacturers/importers and wholesalers
- Manage (local) Technical Agreements, Supplier qualification
- Management of PMSIs and incidents, CAPAs, Changes, Complaints, Self-inspections, Recalls, PQRs
- Review of GMP/GDP documentation and advice with respect to regulations
- Ensure procedures (SOPs/WIs) are in line with EU, international legislation and internal policies and procedures
- Act as (co-)host during internal corporate or external (authorities) audits/inspections
- Act as point of contact for the Competent Authorities on specific issues
Quality AssurancePharmaceutical ManufacturingGMPGDPQPRPSeniorFull-timeHybridNetherlands