Aufgaben

- Responsible to manage and conduct the review of the executed electronic batch record according to SOP
- Ensure that all control parameters for intermediates and biological drug substances are checked for compliance with defined specifications before a batch is dispatched
- Ensure that all open issues within EBRs are explained and closed
- Identify Capas and Deviations and open electronic batch record review

Qualifikationen

- Several years of experience in Quality Assurance in combination with production
- Very good GMP knowledge
- Experience reviewing electronic batch records
- Proficiency in written and spoken English and good German knowledge