IMP QA Manager Clinical Packaging
- Employment type
- Full-time
- Workload
- 100%
- Location
- Kaiseraugst
- Languages
- German, German
- First posted
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 PositionIMP Quality Operations Switzerland is responsible for the cGMP-compliant provision of investigational medicinal products (IMPs) for our patients. We are the Quality Partner for all production units as well as clinical packaging in pharmaceutical technical development in Switzerland and bear the overarching quality and compliance responsibility. We are committed to transforming ourselves from within into a purpose-driven organization based on strength- and role-based working, so that every team member can develop optimally.In this role, you act as the deputy for the technically responsible person (FvP) for IMPs in Switzerland and are responsible for the batch release and certification of IMP finished products. As a Quality Partner, you support end-to-end cGMP activities, ensure the right to operate at the Clinical Packaging site Kaiseraugst and guarantee compliance with regulatory and internal quality standards. The position requires a high degree of flexibility, resilience and a deep sense of responsibility.The OpportunityGMP & operational support: You support quality-relevant packaging processes and work together with operations as well as other stakeholders on GMP topics.Review & release: You manage the review and release of manufacturing specifications and batch records for semi-finished and finished goods.Deviation & change management: You actively control deviations and changes to maintain strict quality compliance.Project participation: You coordinate local as well as global improvement projects and accompany corrective and preventive actions (CAPA).Process optimization: You engage in improvement initiatives and create, review and implement standard operating procedures (SOPs).Cultural contribution: You actively help shape a human-centered, self-organized way of working and drive the cultural change towards more agility and innovation.Who you areEducation: You have a master's degree, preferably in Life Sciences, engineering or a comparable field.Experience: You bring at least 3 years of experience in the pharmaceutical industry (experience in the area of packaging, master data, quality control or quality assurance is a plus).Technical knowledge: You have sound knowledge of cGMP guidelines and quality requirements in clinical development phases.Mindset: You are a solution-oriented team player with high self-motivation, innovative spirit and the ability to inspire others.Languages: Business fluent communication skills in spoken and written German and English are a must.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.
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