Batch Record Reviewer


Bern
Negotiable
CR/562662_1764345013
Batch Record Reviewer

We are currently supporting a global Bio-Pharmaceutical company in their search for an experienced QA Batch Record Reviewer to join their team in Switzerland. This is a fantastic opportunity to take ownership of technically challenging projects in a dynamic and innovative environment.

As a Batch Record Reviewer making sure the batch was made properly, according to procedure and regulatory requirements. Reviewers should have great attention to detail, be able to work independently, and have a thorough knowledge of the manufacturing process they are reviewing

Key Responsibility:

  • Review of the Executed Batch Records (e.g. production documentation review, raw data etc)
  • Support batch release by ensuring the completeness of the documentation package
  • Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
  • Support the initiation of deviations and investigations for Batch Record review related observations

Key Requirement:

  • Academic degree OR relevant work experience in Biology/ Chemistry/ Biotechnology or other related field
  • Previous experience in GMP regulated pharmaceutical / API industry is an advantage
  • Ability to identify non-compliance and gaps from quality standards
  • Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
  • Fluent English (written and verbal) is required, German language skills preferred

Apply now with your CV.

Please note: *** Only candidates with the right to work in Switzerland can be considered (e.g., EU citizens or holders of a valid Swiss work permit).***