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Quality Assurance Associate

May 8 2017
Industries Pharmaceutical, Biotechnology
Categories Quality assurance and control - Validation
Saint-Laurent, QC

Position Summary

The Quality Assurance (QA) Associate is responsible for the activities and quality systems necessary to ensure product released to the market is in full compliance to regulatory standards and Green Cross Biotherapeutics (GCBT) requirements. 

Key Duties and Responsibilities

  • Perform the following day-to-day functions, but not limited to:
    • Approval of Analytical testing results for In-Coming Material, Intermediate and Finished Products
    • Approval of Batch Records for Intermediate and Finished Products
    • Approval of Protocols and Reports related to Installation / Operational / Performance Qualifications
  • Release or Rejection of In-Coming, Intermediate and Finished Products in SAP
  • Resolve and Approve any investigations, non-compliance and quality incidents related to Product Quality and Quality Systems
  • Approve Change Requests related to GMP documents / processes
  • Perform investigations for Customer Complaints
  • Perform Annual Product Reviews for all Finished Products
  • Develop and Report Quality Metrics to management
  • Generate new procedures and revise existing procedures, as required
  • Ensure the integrity and traceability of all data generated and reported
  • Perform additional duties as assigned

Qualifications

  • Education: At minimum, must have a University degree (BSc) in Chemistry, Biochemistry or Microbiology
  • At least 5 years' experience in QA within the Biopharmaceutical or Pharmaceutical Industry
  • Solid understanding of cGMP regulations
  • Good computer skills with MS Office and Adobe Acrobat
  • Strong organizational skills, including attention to detail and ability to meet deadlines
  • Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
  • Must be an able to work independently and as part of a team
  • Able to multi-task under strict deadlines
  • Be proactive and resourceful to help prevent and solve problems
  • Good oral and written communication skills and good interpersonal skills
  • Bilingual in both French and English

 

 

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