Quality Assurance Specialist
- Being part of the Quality Assurance team, reporting into the Head of QA Systems
- Management of change controls
- Participation in planning and execution of site trainings
- Issuance and revision of Product Quality Review (PQR)
- Participation in planning and execution of self-inspections together with CAPA management
- Revision of Master Batch Records
- Issuance of process validation protocols and reports, participation in risk assessment management and cooperation in the revision of qualification and validation documentation
- Overview on Quality Agreement with customers
- Participation in management of regulatory aspects to maintain required manufacturing licenses
- Collection of site KPIs
- Previous experience in a similar role within Quality Assurance departments (around 2 years)
- Comprehensive knowledge of GMP standards and a previous experience in change control, risk assessment management and process validation, basic knowledge of the local and international legal/regulatory requirements
- Degree in Scientific disciplines
- Fluency in English
About Grünenthal
Grünenthal is a global leader in pain management and related diseases. As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.
Grünenthal is headquartered in Aachen, Germany, and has affiliates in 27 countries across Europe, Latin America and the US. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of € 1.8 bn.
Your HR contact:
Maria Elena Vinciguerra