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.