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Careers

Quality Assurance Supervisor

Reference Number: 90
Location Pointe Claire, QC
Reports To: Director of Quality Assurance and Quality Control
 
Description

Overall Job Summary:

The Quality Supervisor is responsible for the maintenance of quality systems, and the release of in-Process Materials and finished products.  They are also responsible for ensuring that the facility remains GMP compliant by managing the internal self-inspection program. 

Specific Accountabilities:

  • Responsible to schedule, coordinate and supervise the work of direct reports, as well as provide coaching, performance management and development.
  • Responsible to act as the Systems Administrator for the electronic documentation management system (eDMS) and quality control computerized equipment.
  • Responsible to identify relevant training needs for plant employees and manage Training Program using eDMS.
  • Responsible for reviewing and approving electronic files (SOPs, forms & WIs) as per approved Change Control, using eDMS.
  • Responsible for managing the quality systems and up-dating related data-bases. (E.g. change controls, deviations, CAPAR, NCR, OOS, etc.)
  • Responsible for maintaining the Site Master File.
  • Responsible for ensuring all required corrective actions and preventive actions are determined and implemented in a timely manner.
  • Responsible for managing the retained samples program (room temperature, quantities, observation, destruction, etc.)
  • Responsible for developing and maintaining a filing, and log system for Quality documents. This will allow for easy retrieval and /or destruction of documents at the appropriate time.
  • Responsible for participating in the review and approval of deviation documents to procedures/processes.
  • Responsible for investigating and documenting trending for deviation reports and issue trending reports as per specified frequency.  Issue CAPAR when required and follow-up on them.
  • Responsible for reviewing all batch documents including manufacturing records and test results and proceed with final release.
  • Responsible for preparing API & finished product certificate of analysis and other documents needed for each batch released.
  • Responsible for acting as a liaison with Endo Pharmaceutical QA to get review/approval of batch release documents.
  • Responsible for managing the internal self-inspection program by being the lead auditor and identifying audit team members, issue reports and perform and document follow-up on corrective actions identified.
  • Responsible for participating in the supervision of Regulatory Agency inspections. Also responsible for developing a program and participating in suppliers and third party laboratory audits.
  • Participate in validation protocols and reports review and approval.
  • Provide back-up to the Director of QA/QC as needed.

Education, Work Experience & Competencies

  • Minimum of a B.Sc. required (Microbiology, Biology, Biochemistry or chemistry)
  • Five years of experience in a pharmaceutical or similar environment coupled with three years of experience in a Quality Assurance role and two years in a supervisory role.
  • Electronic DMS experience is a definite asset
  • In-depth  knowledge of GMPs and Quality Systems
  • Proficient in Windows, Word, Excel, Access and PowerPoint
  • Ability to multi-task
  • Ability to strive for continuous improvement in the development and maintenance of Quality Systems
  • Ability to prioritize and communicate with all levels of employees
  • Positive attitude and professional behavior.
  • Initiative and ability to work with minimal direction

Working Conditions:

This position takes place mainly in an office environment with occasional Manufacturing and Laboratory exposure.

Conclusions:

The Job Description outlines the Key Accountabilities of the position and should not be considered a detailed description of all requirements that may be inherent in the job.

If you are interested in this position, please Apply Online .

Be sure to include the reference number of the position and attach your resume.

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