GMP Compliance Specialist (temporary, 2 years)

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionWe are a dynamic, production-accompanying compliance team in Kaiseraugst! As the compliance group for our pre-filled syringe line (PFS), we are responsible for the quality and regulatory standards during the aseptic filling and processing of syringes under the strictest GMP requirements. In this role as GMP Compliance Specialist (intern: Asset Excellence Manager), you will ensure the continuous GMP compliance and stability of our processes. Your main focus will be on operational compliance - from the timely review of batch documentation (Batch Record Review) to the independent management of deviations (Deviations), CAPAs, and changes (Changes). As a central interface, you will work closely with production, quality assurance (QA), and other support functions to ensure the highest standards in a highly regulated environment.The OpportunityGMP Compliance: Technical responsibility for compliance with national and international GMP rules in the area of sterile filling of pre-filled syringes.Batch Record Review: Timely execution of the control for completeness and accuracy of the Batch Records as well as preparation of the site-side batch closure for handover to QA. Deviation & CAPA Management: Independent processing of events, deviations, and complaints as Owner/SME, conducting root cause analyses (RCA) as well as definition and follow-up of effective CAPAs. Change Management: Sustainable control and processing of change processes as Change Owner or support as a Subject Matter Expert (SME).Audit & Inspection Responsibility: Representation of the area as an SME during internal and external audits as well as authority inspections.Training & Knowledge Management: Creation of training concepts, conducting training, and further development of team members.Operational Excellence & Digitalization: Co-design of digital processes (MES/SAP) as well as use of KPI and LPS tools to increase performance.Who You AreA completed pharmaceutical, natural science, or technical degree or vocational training in combination with 2-3 years of professional experience. Good knowledge or professional experience in pharmaceutical production, development, quality assurance, and control Very good communication skills in written and spoken GermanEnglish skills according to the activities performedHigh level of commitment to the position and the employerOpenness towards new thingsResilience and flexibilityConstant performance capability with changing requirements.Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!  Who we areA healthier future drives us to innovate. Together, more than 100-000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let-s build a healthier future, together.Roche is an Equal Opportunity Employer.