QA Section Manager (Batch Record Review)

  • Posted 3 years ago

Responsibilities

  • Lead projects, provide leadership and develop sub-teams, and train new team members
  • Compile batch documentation for lot release within targets defined by review and release schedule
  • Review of GMP documentation (e.g. manufacturing critical logbooks, change-over records)
  • Full review of completed batch records to ensure cGMP compliance per written procedures
  • Review and approval of Master Batch Records, Manufacturing, MSAT and Program Management SOPs, change requests, deviations, and corrective/preventative actions
  • Manage the Quality Tag Out system for Manufacturing
  • Prepare responses for customer review observations
  • Coordinate lot release activities, as needed
  • Support Customer and/or Regulatory Audits/meetings

Requirements

  • Honours Degree in a relevant science discipline
  • Minimum 5 years of relevant experience in the biopharmaceutical or related industry
  • Extensive knowledge of cGMP requirements
  • Working knowledge of validation
  • Strong planning and supervisory skills
  • Excellent interpersonal, oral and written communication skills
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