Quality Assurance Specialist Sterilproduktion Biologics Drug Product

Responsibilities

• Ensure cGMP compliance within the sterile production and visual inspection processes
• Support qualification and validation activities
• Coordinate and execute all batch release activities in collaboration with the Qualified Person
• Provide on-site support for aseptic manufacturing and visual inspection
• Manage Change Control and Deviations, including root cause analysis and implementation of corrective actions
• Assist in the processing of complaints and the creation of annual Product Quality Reviews
• Prepare country-specific certificates and support dossier creation and regulatory inspections
• Review and update process-relevant Standard Operating Procedures (SOPs)

Requirements

• Practical experience in the pharmaceutical industry within a GMP environment (e.g., Quality Assurance, Quality Control, or Production)
• Proven experience in establishing and maintaining GMP and regulatory compliance
• Strong knowledge of national and international current GMP standards, including EU and FDA regulations
• Diploma or Master's degree in Pharmacy or Natural Sciences (PhD is an advantage)
• Fluent German and good English language skills
• Strong organizational, communication, and teamwork skills with a high degree of self-motivation

Benefits

• An attractive, market-oriented compensation and benefits package
• Company pension scheme
• Individualized and structured onboarding process
• Mobility budget to support your commute
• Opportunities for professional development and career advancement within an international environment

About the Company

Sanofi is a research-driven biopharmaceutical company that uses AI to improve lives and grow responsibly. With a deep understanding of the immune system, we develop medicines and vaccines that treat and protect millions of people worldwide. We combine cutting-edge science with state-of-the-art manufacturing to deliver healthcare breakthroughs to patients globally.