Quality Assurance Specialist / Spécialiste de l’assurance de la qualité

Pfizer • Brandon, MB

22h • Onsite

About The Position

The Quality Assurance Specialist is responsible for disposition of the API and API intermediates, including the review of completed batch production and laboratory control records of critical process steps before disposition and ensuring that deviations are investigated and resolved. The incumbent is responsible for the disposition of Active Pharmaceutical Ingredients (APIs) and intermediate products. In the plant, in addition to providing quality assurance support during batch manufacturing, they are responsible for reviewing completed batch production and laboratory control records, verifying their accuracy, identifying errors, determining the causes of these errors, and identifying trends related to irregularities. They act as the lead investigator for investigations concerning anomalies that occur during manufacturing, approve changes to Good Manufacturing Practice (GMP) procedures, protocols, forms, and directives, and review and approve laboratory analysis reports and take necessary corrective or preventive actions. The Quality Assurance Specialist must also collaborate in the review of evaluation requests, the preparation of annual product reviews and water quality trend reports, and perform audit and trend evaluation reports as needed.

Requirements

• Post-Secondary Education (Degree/Diploma) or relevant Quality experience
• Knowledge of Quality Systems and cGMP in a pharmaceutical setting
• Must have very good inter-personal skills, ability to prioritize and meet deadlines
• Must learn quickly, be intuitive and self-reliant
• Must have effective oral and written communication skills and be able to process procedure and form revisions
• Computer skills – MS Office (Word, Excel, Power Point)

Responsibilities

• Acts as a lead investigator
• Reviews production batch records
• Performs quality and compliance related activities as assigned
• Tracks and trends data for annual product review, water trend reports, and metrics.
• Authors and/or coordinates the completion of assigned reports.
• Provides final review and approval of CAPA, laboratory investigations and GMP procedures, protocols, forms and instructions; ensuring compliance to cGMPs, regulatory filings, and Pfizer policies/procedures.
• Performs or assists with audits and participates in inspection readiness plans and activities
• Administrating the document management and change control processes
• Maintaining a stability program to support retest or expiry dates and storage conditions

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree