Quality Assurance Specialist - Couvet Site (Neuchâtel)

The position supports our Quality Assurance Manager by establishing and maintaining the company’s entire operational & quality system.Tasks And ResponsibilitiesMonitor data and key performances indicators to ensure continuous improvementPrepare, evaluate and approve controlled documents and GMP-related documentation in collaboration with other department managersActively participate in the preparation and management of regulatory inspections and customer audits. Act as a reference or support person when responding to observations. Contribute to the follow-up of post-inspection commitmentsConduct internal GMP audits and participate in regulatory inspectionsLead and review deviation investigations, root cause analysis, impact assessments, and corrective/preventive actionsContribute to the complaint’s investigation in collaboration with involved managers and follow-up with the customersDefine and implement the strategy for equipment qualification and validation of manufacturing, cleaning and sterilization processes and analytical methods.Evaluate and approve change controls, ensuring implementation and complianceParticipate in the Supplier qualification and their periodic requalification, if neededIssuance of Master Batch Records, batch record review and release activitiesProvide training on GMP, GDP and quality related topics.Required Skills And Core CompetencesBachelor/Master degree in related technical science (pharmacy, chemistry or equivalent)5-7 years’ experience in the pharmaceutical field, QA & production. Experience gained preferably in small-medium pharmaceuticals with marketing authorization released by the local health authoritiesKnowledge of the pharmaceutical industry and expertise in injectables production both aseptic and terminally sterilized processes with strong knowledge of aseptic behavior and ability to ensure compliance with aseptic techniques in classified areasPractical understanding and application of a Contamination Control Strategy in sterile manufacturingSolid expertise in Annex 1 (EU GMP) requirements, including interventions in classified areas and contamination risk controlFrench and English fluentGood experience in the use of MS softwareStrong relational, communication, adaptability, proactive approach, pragmatic and problem-solving skills360° commitment to develop expertise in activities requiring high flexibilityAble to work independently and as part of a team to complete assigned tasks within established deadlines. #J-18808-Ljbffr