QA Systems Specialist

17 ott - Origgio
Grünenthal Group

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 Like 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 areas for improvement and driving related action plans
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