• Contract
  • Valais
  • Recruiter: Anil Dahiya

Batch Record Reviewer – 5927 ADA

 

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Batch Record Reviewer for a contract role until the end of year. (extension planned) based in the Valais area, Switzerland.

 

This Batch Record Reviewer will have a close collaboration with the Bioprocess Engineers and Quality Assurance regarding the products produced and their good documentation practice.

 

Main 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

Qualifications and Experience:

·       Relevant working/residency permit or Swiss/EU-Citizenship required

·       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

·       Strong team spirit required

·       GMP experience an advantage

·       English mandatory / German a real plus