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Quality Assurance Team Lead

2 months ago

Laval, Quebec, Canada Team Aaa Full time
Job Description

Job Summary:

We are seeking a highly skilled Quality Assurance Team Lead to join our team at Team Aaa. As a key member of our organization, you will be responsible for ensuring the coordination of compliance activities, including supplier management, licensing quality agreements, internal audit, and investigations.

Key Responsibilities:

  • Coordinate compliance activities, including supplier management, licensing quality agreements, internal audit, and investigations.
  • Ensure coordination of activities internally related to these compliance systems and track key performance indicators (KPIs).
  • Supervise compliance specialists responsible for tasks related to compliance activities.
  • Ensure supplier program is up to date.
  • Coordinate external audits.
  • Perform supplier reviews and coordinate supplier issues and communications with procurement.
  • Manage quality agreement updates within required timelines.
  • Coordinate new quality agreements issuance.
  • Provide quality support for investigations and participate in SWOT team activities for site investigations.
  • Manage the investigations system, ensuring investigations are completed on time and as per requirements.
  • Provide KPIs for investigations.
  • Responsible for the internal audit program.
  • Provide KPIs for internal audit.
  • Responsible for filing of DELs, Table A, and other site licenses.

Requirements:

  • Bachelor's degree in science or equivalent combination of experience and academic education.
  • Minimum 5 years' experience in a pharmaceutical industry.
  • Experience required in GMP, quality systems, investigation writing, and audit.
  • GMP knowledge.
  • Knowledge of investigation writing tools (5 whys/ Ishikawa).
  • Knowledge of production flows/steps.
  • Knowledge of use of Microsoft Office tools.

Location: This position may be available in various locations.