Senior Lead, QA (LBS-Deviation)

  • Posted 3 years ago

Responsibilities

  • Work as part of the QA Operations team
  • Review and approve of SOPs, changes, deviations, and corrective/preventative actions
  • Maintenance of quality systems and cGMP compliance for the business
  • Batch Record Management – full review of completed batch records to ensure compliance with cGMP, and compile batch documentation for lot release
  • Deviation Management – assess potential impact to product quality for open deviations during lot release, and ensure all associated deviations are investigated and closed prior to lot release
  • Document Management – review GMP documentation (e.g. manufacturing logbooks), prepare and load documents into share point, prepare monthly management report
  • Interact with the clients on a regular basis
  • Prepare responses for customer review observations
  • Prepare/Compile metrics for Quality Council and other forums
  • Perform external/internal audits as needed
  • Support Annual Product Reviews, Customer and/or Regulatory Audits or Meetings

Requirements

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