| Reference Number: 90 |
| Location |
Pointe Claire, QC |
| Reports To: |
Director of Quality Assurance and Quality Control |
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| 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:
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Responsible to schedule, coordinate and supervise the work of direct reports, as well as provide coaching, performance management and development.
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Responsible to act as the Systems Administrator for the electronic documentation management system (eDMS) and quality control computerized equipment.
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Responsible to identify relevant training needs for plant employees and manage Training Program using eDMS.
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Responsible for reviewing and approving electronic files (SOPs, forms & WIs) as per approved Change Control, using eDMS.
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Responsible for managing the quality systems and up-dating related data-bases. (E.g. change controls, deviations, CAPAR, NCR, OOS, etc.)
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Responsible for maintaining the Site Master File.
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Responsible for ensuring all required corrective actions and preventive actions are determined and implemented in a timely manner.
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Responsible for managing the retained samples program (room temperature, quantities, observation, destruction, etc.)
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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.
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Responsible for participating in the review and approval of deviation documents to procedures/processes.
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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.
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Responsible for reviewing all batch documents including manufacturing records and test results and proceed with final release.
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Responsible for preparing API & finished product certificate of analysis and other documents needed for each batch released.
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Responsible for acting as a liaison with Endo Pharmaceutical QA to get review/approval of batch release documents.
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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.
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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.
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Participate in validation protocols and reports review and approval.
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Provide back-up to the Director of QA/QC as needed.
Education, Work Experience & Competencies
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Minimum of a B.Sc. required (Microbiology, Biology, Biochemistry or chemistry)
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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.
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Electronic DMS experience is a definite asset
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In-depth knowledge of GMPs and Quality Systems
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Proficient in Windows, Word, Excel, Access and PowerPoint
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Ability to multi-task
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Ability to strive for continuous improvement in the development and maintenance of Quality Systems
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Ability to prioritize and communicate with all levels of employees
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Positive attitude and professional behavior.
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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.
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Be sure to include the reference number of the position and attach your resume.
