Representative QA Operations (m/w/d) - Analytical & Quality Evaluation Research Laboratories

Responsibilities

• Monitor GMP compliance and system compliance within the Analytical & Quality Evaluation Research Laboratories (AQERL)
• Create, review, approve, and release GMP documents including SOPs, risk analyses, and manufacturing instructions
• Support the evaluation and processing of deviations and out-of-specification test results
• Define and track Corrective and Preventive Actions (CAPAs)
• Participate in Change Control processes by drafting, reviewing, and tracking measures
• Conduct GMP training within the specialized department
• Assist in the preparation and execution of audits and self-inspections
• Contribute to the continuous development and maintenance of the Quality Management System
• Support the department with validations, qualifications, method transfers, and inspections

Requirements

• University degree in Life Sciences (e.g., Pharmacy, Biotechnology, or similar)
• Several years of professional experience in the pharmaceutical industry, preferably in Quality Management
• Strong knowledge of national and international GxP regulations
• Proficiency in MS Office; basic knowledge of SAP is desirable
• Fluency in German (written and spoken) and proficiency in English
• Structured, independent, and reliable working style
• Ability to work effectively in a multinational and multicultural team environment

About the Company

Daiichi Sankyo is a global healthcare company dedicated to improving lives through innovative medicines. With a legacy dating back to 1899 and a presence in over 30 countries, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. We foster a culture of mutual respect, continuous learning, and inclusion to shape a healthier future for patients worldwide.