Quality Assurance Specialist

March 18 2020
Categories Production, Operations, Quality, Safety, Pharma, Biotech, Sciences, R&D, Quality assurance and control, Validation
Montreal, QC

Job Summary

  • Maintain, implement and improve of the established Quality System.
  • Perform day-to-day quality assurance activities.


  • Release products for distribution in compliance with internal quality standards and regulatory requirements.
  • Manage deviation, non-conformity, change control and complaint and prepare risk assessment and propose corrective and preventive action (CAPA) as required.
  • Prepare, review, and/or approve specifications and standard operating procedures (SOP).
  • Maintain documentations and recording in compliance with GMP requirements.
  • Prepare and approve annual product quality review (APQR).
  • Evaluate and ensure the disposition of returned products.
  • Communicate quality matters with vendors and suppliers as well as internally with other Euro-Pharm Departments and determine what actions to take to resolve the issues.
  • Participate in internal audit program and take CAPA as required.
  • Maintain and improve QA documentation and archiving system.
  • Perform other tasks pertaining to QA and QC activities delegated by supervisor.

Education: Minimum a B.Sc. in Science

Experience: +5 years' experience in pharmaceutical industry, +3 years' experience in Quality Assurance

Technical Know-How: Strong knowledge in cGMPs, ICH, Pharmacopeia.  Knowledge in in Quality Assurance and Quality control.  Good knowledge of Microsoft Office and Outlook programs.

Other Criteria:

  • Bilingualism: EN and FR, oral and written.
  • Excellent communication skills.
  • Multitasker.
  • Results oriented.
  • Have attention to detail.
  • Ability to prioritize and manage time.
  • Must be a team player.
  • Be punctual and have an excellent attendance record. 
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