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Batch Record Reviewer

vor 2 Wochen

Visp Valais, Schweiz Hays Vollzeit CHF 60'000 - CHF 90'000 pro Jahr

For our international pharma client we are looking for a
Batch Record Reviewer (m/f/d).

Duration: 9 months

Location: Visp

Workload: 100%

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.

Responsibilities

  • Review Executed Batch Records including production documentation, raw data, and supporting materials
  • Support batch release by ensuring the completeness and accuracy of the documentation package
  • Evaluate comments added to Executed Batch Records, clarify with the operations team, and escalate to the responsible QA Manager when needed
  • Initiate deviations and investigations related to Batch Record review observations, ensuring compliance with GMP and regulatory standards

Requirements

  • 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