Project Leader, QA Approver

Job Summary

Responsible for conducting, reviewing and approving investigation reports at Apotex site and ensure that investigations are conducted in a timely and efficient manner leading to root cause elucidation. Review and approval of QC Laboratory change controls and supporting documentation (as applicable).  Accountable to ensure that established procedures on how to report and investigate deviations are followed and appropriate corrective actions / preventative actions (CAPA) are identified and implemented.

Job Responsibilities

1. Responsible for leading investigation of event with potential to impact batch/product on the market (g., critical complaints, OOS stability results).
2. Escalate and work with site management team to manage the escalate process for critical events (e.g., critical complaints, OOS stability results).
3. Oversees and acts as Quality Approver and SME for deviation investigations at a site level and ensures investigations are initiated following existing procedures.
4. Acts as resource providing support & guidance to QA Approvers and Lead Investigators. Provides training to new Project Leaders.
5. As needed assist with assignment of the work to other Project Leaders, QA Approvers and provides guidance with critical/complex investigations.
6. Liaise with internal customers and stake holders to review and discuss deviation root causes and proposed CAPAs for critical or complex investigations and provides QA recommendations regarding actions such as blocking of Master Formula or initiating process optimization investigations with Technical or Analytical Operations.
7. Provides QA review and approval of QC Laboratory Investigation Reports (LIR) relating to confirmed OOT/OOS results to ensure investigations are initiated in timely manner, review LIRs for accuracy and completeness.
8. Provides quality review and approval of site deviation investigations. Ensures that investigations identify the root cause and the impact is assessed and the corrective and preventative actions are appropriate for all complete investigations.
9. Identifies gaps of current quality systems and/or procedures impacted by implementation of proposed preventative actions. Liaise with given department to ensure system/procedures are revised.
10. Monitors the investigation timelines to ensure investigations are completed within the 30 days and, if required, ensures extensions are approved prior to due date with realistic justification.
11. Attends meetings as required and or hosts meetings with investigators, subject matter experts and other relevant groups as required to determine root cause and CAPAs.
12. Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities.
13. Works as a member of a team to achieve all outcomes.
14. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
15. Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
16. Perform all other relevant duties as assigned.

Job Requirements

• Education: Bachelor of Science Degree is preferred (or an asset)
• Knowledge, Skills and Abilities:
  • Experience in project management and fluency in project management RCCA tools
  • Superior organizational, interpersonal and communication skills
  • Ability to work independently and manage multiple priorities in a fast-paced environment
  • Good command of the English language, both written and verbal
  • Knowledge of GMP and fluency in RCCA tools
  • Proficiency with Microsoft Office (Word & Excel), Trackwise, Labware LIMS and SAP
• Experience:

• Minimum 5 years of professional related experience in Quality Assurance within a pharmaceutical manufacturing environment.
• 3 years of past QC laboratory experience strongly preferred
• Experience in project management