Quality Manager - Swisslinx

Job description:Start: ASAPDuration: 6 monthsLocation: BaselRequirements:Serve as the primary quality contact for all communications related to drug substance and drug product PPQReview and approve PPQ documentation including protocols, reports and discrepanciesReview executed PPQ batch records and ensure accurate transcription into reportsEnsure discrepancies during execution are fully investigated and assessed for PPQ impactParticipate in FMEA and other risk-based activities to evaluate process performanceProvide regular updates on PPQ progress and escalate delays, failures or issues in a timely wayAct as the main quality representative in project teams, escalating when needed and ensuring cross-functional alignmentOccasional travel may be requiredCompetences:Minimum 5 years of experience in Quality or Process ValidationStrong GMP knowledge, especially for small molecule drug substance and drug product operationsSkilled in managing multiple priorities in a fast-paced environmentExperience collaborating with CMC, regulatory, MSAT and other quality functions across countries and time zonesStrong ability to evaluate quality risks and propose mitigation strategiesBSc in a relevant scientific disciplineStrong PC skills including MS Office