Key Responsibilities :
- Independent review of operational paper-based and electronic manufacturing records on schedule :
- Checking whether the materials used were approved at the time of production
- Carrying out the audit trail reviews
- Checking whether required Filter Integrity Tests (FIT) are available and have been successfully completed
- Check whether trends, parameters and CPP are within the given limits
- Checking the LIMS labels for correct labeling in the manufacturing protocols
- Creating and editing CAPAs in the Trackwise system
- Collaboration in continuous improvement processes in the BRR area
- Supporting the other BRR departments (QA, BPE)
- Participation in cross-departmental meetings (QA, BPEs)
- Implementation of logbook reviews
Requirements :
Mandatory : Proficiency in English; German is a real plus.Completed vocational training.Strong attention to detail and excellent documentation skills.High safety and quality awareness.Strong team spirit.Advantageous : GMP experience.Advantageous : Bachelor's degree in science, engineering, chemistry, biology, or a related field.If you meet the requirements and are interested in joining our dynamic team, please submit your application.
We look forward to receiving your application!