Batch Record Reviewer

Updated: May 24, 2024 01:46 PM GMT

Actalent

Visp

One of my major client, is currently seeking a dynamic Batch Record Reviewer to join their team and drive supplier excellence, working closely in collaboration with the Bioprocess Engineers and Quality Assurance regarding the products produced and their good documentation practice.

As the Batch Record Reviewer you will be in charge of the independent review of operational paper-based and electronic manufacturing records.

Responsibilities:
• 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)
•... More Detail