- Execution and review of batch record reviews for cell cultures
- Coordination with other departments, representing QA in technical matters
- Providing structured documentation to support QA release
- Communication with the operations team regarding deviations and batch record reviews
- Review and final approval of manufacturing documents such as SOPs, master manufacturing batch records, CAPAs, change requests, effectiveness checks, testing protocols, and reports
- Participation in OOS (Out of Specification) investigations, audits
- Authoring and approval of SOPs
- KPI (Key Performance Indicator) data management and evaluation


- Bachelor's degree with a relevant specialization (such as chemistry, biotechnology, bioengineering) or equivalent work experience in the production field
- Previous experience in the GMP-regulated biopharmaceutical industry is advantageous
- Strong analytical skills
- Excellent communication skills and coordination with various interfaces within the organization
- Structured, focused, and well-organized work ethic
- Openness to new ideas and suggestions; solution-oriented
- Agile, highly motivated, and dynamic approach
- Ability to deliver reliable results in a dynamic environment
- Proficiency in written and spoken English, with German language proficiency being advantageous