Senior QA Expert for QC Specialist (7084)

ppbSenior QA Expert for QC – 7084 URA /b /ppOur client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a bSenior QA Expert for QC /bThe Sr. QA Expert for QC role is a 6M contract with b60% workload /b. QA responsible for QC oversight to support departmental projects and objectives according to agreed timelines. Ensures adherence to standards and compliance with GMP regulation in btheir manufacturing unit in Stein /b. Review, approve and release of all batch-related microbiology documents. b100% onsite /b presence will be required. /ppThe Project is related to implementation of a laboratory management system gLIMS. The candidate must have 2+ years of experience with LIMS. The candidate must have 7+ years of Quality Assurance experience (a mix of QA and QC is acceptable). /ph3Main Responsibilities: /h3ulliCollaborate 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. /liliProvides guidance and quality oversight for QC /liliSupport growth projects and act as primary point of contact in QA for implementation of gLIMS (laboratory execution system) /liliRepresents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met and SOPs are followed. /liliReview and Approval of GMP relevant documents from quality control, includingSOPs with focus on implementation of gLIMS. /liliSupervise and execute GMP compliance activities like changes (CRs), document management, non-conformities (DRs) /liliWrite or revise SOPs in the area of expertise and be the owner of these documents. /liliSupport QA for QC raw data review, as deemed required /liliMeet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.) /liliManagement and reporting of KPIs /liliPerform/support inspections and audits as required. /liliPerforms other duties as assigned /li /ulh3Qualifications and Experience: /h3ulliRelevant working/residency permit or Swiss/EU-Citizenship required /lili8 years + experience in projects in implementation of laboratory execution systems, within a quality-focused environment. /liliStrong background in cGMP regulations, including US, European and Japanese Pharmacopoeia. /liliVery good knowledge in laboratories/laboratory equipment/software qualification/validation. /liliExperiencein interaction with health authorities (FDA, Swissmedic, etc.). /liliStructured, focused and well-organized working attitude. /liliOpen-minded for new ideas and suggestions, agile, highly motivated and dynamic drive. /liliPragmatic and solution-orientated mindset. /liliFluent in English, German language is nice to have /liliProject management certification would be considered as advantage (Green/Black Belt etc /li /ul /p #J-18808-Ljbffr