Quality Assurance Employee (m/f/d)

Do you have a keen eye for detail and want to actively contribute to the safety of high-quality pharmaceuticals? For our renowned pharmaceutical client in Mannheim , we are immediately seeking a dedicated individual to fill the role of Specialist Batch Record Review . Become part of a cross-functional team and help shape innovative quality processes in a future-proof work environment!

Here's what we offer

• Attractive salary and long-term job security through affiliation with a large corporation.
• Up to 30 days of vacation per year
• Company pension scheme contribution after the end of the probationary period
• Extensive social benefits, including Christmas and holiday pay

Your tasks

• GMP-compliant batch testing: You conduct batch record reviews across the value stream, check manufacturing documentation for completeness and logic, and ensure compliance with data integrity (ALCOA+).
• Process & Data Analysis: Based on your in-depth understanding of processes, you identify and evaluate trends and critical process data using statistical concepts and communicate these to production.
• Deviation management: You initiate and process deviations within the review process and support the operational units with live batch issues during ongoing production.
• Audit & inspection support: You professionally prepare relevant batch documentation and review processes and confidently present them during internal audits and official inspections.
• Knowledge multiplier in the team: You take on an expert role for complex questions in the area of Batch Record Review and pass on your specialist knowledge to colleagues in a targeted manner.

Your profile

• Completed studies (e.g. pharmacy, biology, engineering) or completed scientific-technical training with further education as a master craftsman or technician (m/f/d).
• Solid professional experience in GMP-regulated pharmaceutical production (ideally parenteral/sterile or biological drugs) as well as experience in batch documentation review or aseptic production.
• Very good knowledge of the common GMP guidelines (EU-GMP, 21 CFR Part 210/211), document management and relevant hygiene regulations.
• Proficient use of relevant IT systems (MES, SAP, MS Office) combined with strong analytical skills and basic statistical understanding.
• Excellent German skills, both written and spoken, as well as good English skills for confident communication in international project and audit environments.