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Batch Record Reviewer

  • Location: Switzerland
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 13 days ago

Key responsibilities:

  • Review of the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks)
  • 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
  • Collect and evaluate on a regular basis KPI data
  • Write and revise SOPs in his/her area of expertise

Key requirements:

  • Bachelor degree or equivalent
  • Previous experience in GDP and 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
  • German and English (fluent)

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