- Bachelor of Science in a science-related discipline
- Knowledge of Canadian GMP’s and all relevant Health Canada Policies and Guidances
- Minimum 5 years experience in the pharmaceutical industry within a QA capacity
- Knowledge of Canadian GMP’s and all relevant Health Canada Policies and Guidances.
- Bachelor of Science in a science-related discipline. Post graduate training in Pharmaceutical Quality Studies an asset.
- Minimum 5 years experience in the pharmaceutical industry within a QA and supervisory capacity.
- 2+ years of QA product release experience.
- Ability to coordinate and manage multiple projects simultaneously.
- Ability to work independently and make decisions based on judgment and integrity.
- Ability to work in a fast-paced environment.
- Good interpersonal skills; ability to interact with staff, clients and key stakeholders on all levels.
- Experience with Inventory Management system.
- Responsible for writing, reviewing, and revising SOPs and quality policies ensuring GMP, regulatory and customer requirements are met.
- Responsible for the release of finished products to market - ensuring that all GMP documentation is correct and compliant.
- Coordinating, tracking, and approving method transfers and finished product testing with the contract laboratory.
- Assisting with recall of any defective products.
- Coordinate with Warehouse staff for incoming product inspection and label review.
- Maintaining retain sample inventory for all products.
- Communicate documentation and release issues, including delays in receiving documentation from Contract Fabricators, deviation investigations, corrective and preventative actions, out of specification investigations, etc.
- Review of Executed Batch Records.
- Collect and/or review technical records for method and process validation protocols and reports.
- Tracking stability for commercial and submission lots on an ongoing basis and ensuring stability for products to support shelf life is filed.
- Working with 3rd party and foreign site organizations on GMP matters to resolve quality matters as require and/or meet Canadian GMP requirements
- Responsible for the GMP and SOP Training of all staff members and warehouse personnel.
- Responsible for the tracking, review, investigation and resolution of product complaints.
- Responsible for the approval of change controls and verifying all Post-NOC and quality requirements are met.
- Responsible for approval of contract fabricator change controls in coordination with regulatory affairs and ensuring all post-NOC requirements are met.
- Responsible for approval of master production documents.
- Review of Annual Product Quality Reports (APQRs) to verify alignment of changes on record.
Manager, Quality Assurance - PharmaToronto, ON, Canada
Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit www.kellyscientific.com to learn more and view a full listing of our opportunities.
MANAGER, QUALITY ASSURANCE - Pharma
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001396
Date Posted: 03/07/2019