Assurance Specialist

3 weeks ago


Montreal, Quebec, Canada Pharmascience Full time
Job Summary

The role of QA Specialist at Pharmascience involves ensuring the application of Good Manufacturing Practices (GMPs) and Canadian and international regulatory requirements. This position requires participation in various quality activities related to product release and coordination of quality and compliance aspects between Pharmascience, subcontractors, and clients.

Key Responsibilities:

  • Review documentation and approve or reject lots according to established checklists.
  • Perform lot status changes in SAP.
  • Contribute to the implementation of change actions related to product release.
  • Coordinate with the supply group to establish priorities for lot release.
  • Maintain up-to-date reference tables and other communication and prioritization tools.
  • Contribute effectively to various initiatives and projects with multidisciplinary teams.
  • Prepare Certificate of Manufacturing for products sold to external clients.
  • Approve Quarantine Use authorizations.
  • Contribute to the Change Control and CAPA processes related to product release.

Requirements:

  • Minimum Bachelor's degree in a scientific discipline or equivalent experience.
  • Minimum 2 years' experience in the pharmaceutical industry.
  • Bilingual oral and written skills in English and French to communicate with suppliers outside Quebec.
  • Observation skills, thoroughness, and rigor.
  • Ability to make decisions and communicate them tactfully and diplomatically.
  • Excellent interpersonal and communication skills.
  • Planning and organizational skills.
  • Competence with MS Office and SAP (an asset).
  • Ability to write and interpret technical documents.


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