QA Systems Specialist

20 ott - Oggiona
Grünenthal

Pay Range (tempo pieno): EUR 37.000 - 43.000​Professional | Permanent | Full-time | On-Site​Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.What the job looks likeEach day you'll enjoy a variety of challenges, such as:• Coordinating Change Control processes, ensuring timely assessment, implementation and effectiveness verification• Supporting the development and execution of site training plans to ensure compliance with GMP and quality requirements• Coordinating the preparation, review and approval of Product Quality Reviews (PQRs),



identifying trends and improvement opportunities• Planning and leading self-inspections, facilitating CAPA definition, implementation and effectiveness monitoring• Providing QA oversight for the review and approval of Master Batch Records and associated GMP documentation• Leading the preparation and review of process validation protocols and reports in collaboration with cross-functional teams• Facilitating risk assessment activities and promoting quality risk management principles across site operations• Providing strategic QA support for qualification and validation lifecycle activities• Overseeing Quality Agreements with customers and external partners, ensuring alignment with regulatory and business requirements• Supporting regulatory compliance activities and maintaining readiness for inspections and manufacturing license requirements• Monitoring and trending site Quality KPIs, identifying area

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