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Batch Record Reviewer

m/w/d, Wallis

You will be in a close collaboration with the Bioprocess Engineers and Quality Assurance regarding the products produced and their good documentation practice

Start date: Immediately

End date: 31.12.2024

Your tasks:

- Independent review of operational paper-based and electronic manufacturing records on schedule:

o Checking whether the materials used were approved at the time of production

o Carrying out the audit trail reviews

o Checking whether required Filter Integrity Tests (FIT) are available and have been successfully completed

o Check whether trends, parameters and CPP are within the given limits

o Checking the LIMS labels for correct labeling in the manufacturing protocols

o 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

- Bachelor's degree (science, engineering) in chemistry, biology or similar is an advantage

- Completed vocational training required

- Accurate working and documentation skills required

- Execution of work with high safety and quality awareness required

- GMP experience an advantage