Project Leader, QA Approver

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Job Summary

Responsible for reviewing and approving deviation investigations at the site level for Apotex OLD to ensure that investigations are conducted in a timely and efficient manner leading to root cause elucidation. Accountable to ensure that established procedures on how to report and investigate deviations using validated electronic systems and appropriate corrective actions / preventative actions (CAPA) are identified and implemented. Acts as senior QA Approver for complex investigations with impact to multiple products and / or batches and provides background, and prepares presentations with recommendations to support risk assessment decisions to Site Senior Management.

Job Responsibilities

• Oversees and acts as Quality Approver and SME for Apotex OLD deviations (Production, Production Technical, In-process, Customer Complaints and QC laboratory failures) at a site level and ensures investigations are initiated following existing procedure.
• Provides support and guidance to QA Approvers and Lead Investigators.
• Assists with assignment of work to Project Leaders, QA Approvers and provides guidance with complex investigations impacting multiple batches and / or products.
• Provides QA approval to allow production to proceed with manufacturing based on preliminary investigation findings and root cause analysis, provided necessary adjustments have been made to restore equipment / facilities to full operation.
• Liaises with internal customers to review and discuss deviation root causes and proposed CAPAs for complex investigations and provides QA recommendations regarding actions such as blocking Master Formula or initiating process optimization investigations with Technical Operations or Analytical Operations.
• Provides training to new Project Leaders.
• Fosters a positive and collaborative team environment and monitors performance, providing regular updates to the Associate Director and relevant department members.
• Provides direction, reviews and approves relevant sections of investigations drafted by Lead Investigators.
• Ensures adherence to deviation investigation processes and timelines, including determining true root cause and appropriate CAPAs, and extensions.
• Approves Production, Production Technical, In-process, Customer Complaints and QC laboratory incidents or deviations in validated electronic systems at a site level for Apotex OLD.
• Revises existing procedures as necessary.

Other Responsibilities

General

All other relevant duties as assigned.

Job Requirements

Education

Knowledge, Skills and Abilities

Experience

Experience in project management is an asset.

At Apotex, we are committed to fostering a welcoming and accessible work environment, where everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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