Tasks

- Execution and review of batch records
- Coordination with other departments, representing QA in technical aspects as well as a role model
- Provide structured documentation to support QA release
- Communication with operations team due to deviations and batch record review
- Review and final release of manufacturing documents such as SOPs, master manufacturing batch records, Capas, change requests, effectiveness checks, testing protocols and reports
- Authoring / approval of SOPs
- KPI Data management and evaluation

Qualifications

- Bachelor degree with relevant specialisation (such as chemistry, biotechnology, bioengineering) or equivalent working experience in the production field
- Previous experience in a GMP regulated biopharmaceutical industry is an advantage
- Strong analytical skills
- Very good communication skills and coordination with different interfaces within the
organization
- Structured, focused and well-organized working attitude
- Open-minded for new ideas and suggestions; solution-oriented
- Agile, highly motivated and dynamic drive
- Ability to produce reliable results in a dynamic environment
- Fluent in English, both written and spoken, German is an advantage