h3Main Responsibilities: /h3 ul liCollaborate closely with cross-functional teams to work on growth projects as per site quality objectives and strategic goals. Ensure that project timelines and deliverables under the responsibility of QA/QC are fulfilled. /li liProvides guidance and quality oversight for QC /li liSupport growth projects and act as primary point of contact in QA for implementation of gLIMS (laboratory execution system) /li liRepresents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met and SOPs are followed. /li liReview and Approval of GMP relevant documents from quality control, including SOPs with focus on implementation of gLIMS. /li liSupervise and execute GMP compliance activities like changes (CRs), document management, non-conformities (DRs) /li liWrite or revise SOPs in the area of expertise and be the owner of these documents. /li liSupport QA for QC raw data review, as deemed required /li liMeet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.) /li liManagement and reporting of KPIs /li liPerform/support inspections and audits as required. /li liPerforms other duties as assigned /li /ul h3Qualifications and Experience: /h3 ul liRelevant working/residency permit or Swiss/EU-Citizenship required /li li8 years + experience in projects in implementation of laboratory execution systems, within a quality-focused environment. /li liStrong background in cGMP regulations, including US, European and Japanese Pharmacopoeia. /li liVery good knowledge in laboratories/laboratory equipment/software qualification/validation. /li liExperience in interaction with health authorities (FDA, Swissmedic, etc.). /li liStructured, focused and well-organized working attitude. /li liOpen-minded for new ideas and suggestions, agile, highly motivated and dynamic drive. /li liPragmatic and solution-orientated mindset. /li liFluent in English, German language is nice to have /li liProject management certification would be considered as advantage (Green/Black Belt etc) /li /ul #J-18808-Ljbffr
Senior QA Expert for QC Specialist
