Qualified Person (m\f\d)
Exciting Opportunity: Qualified Person (m\f\d)
Are you a dynamic and detail-oriented professional seeking to make a real impact in the pharmaceutical sector? Our client in Hessen region, Germany, is looking for a committed and experienced Qualified Person (QP) to join their team. This permanent position offers the chance to oversee the release of innovative drug-device combination products, ensuring the highest standards of quality and compliance. As part of our client's team, you will gain exposure to a variety of products and have the opportunity to work alongside global experts in driving compliance and enhancing quality excellence.
Key Responsibilities
- Release finished medicinal products and bulk goods in compliance with GMP and regulatory requirements.
- Collaborate with cross-functional teams to ensure manufacturing instructions meet marketing authorizations and process validation standards.
- Act as the responsible quality expert during audits and self-inspections.
- Address quality-related inquiries and ensure strict adherence to Annex 16 of the EU GMP Guide.
- Coordinate investigations, assess deviations, and monitor changes, CAPA elements, and complaints for timely resolution.
- Maintain the GMP status of the site and manufacturing processes.
Required Skills
- 2-5 years of experience as a Qualified Person.
- Knowledge of regulations for medicinal products, medical devices, and combination products.
- Strong understanding of production processes and quality systems, supported by proficiency in MS Office and SAP.
- Fluent in both German and English, with strong communication and teamwork skills.
- Analytical mindset with solution-oriented thinking and meticulous attention to detail.
- Willingness to travel as required.
Join our client's innovative team dedicated to delivering life-extending, highly effective medicines to global markets. Apply now and take the next step in your career as a Qualified Person with our client.
FAQs
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