Project Leader, QA Approver

Job Summary

Responsible for conducting, reviewing and approving investigation reports at Apotex site and 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 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 (e.g. critical complaints, OOS stability results).
2. Escalate and work with site management team to manage the escalation process for critical events (e.g. critical complaints, OOS stability results).
3. Oversees and acts as Quality Approver and SME for deviation investigations at the site level and ensures investigations are initiated following existing procedures.
4. Acts as resource providing support and 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 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 true root cause and appropriate 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. Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.

Perform all other relevant duties as assigned

Job Requirements

• Education
  • Bachelor of Science Degree or equivalent in a related discipline
• Knowledge, Skills and Abilities
  • Excellent written and verbal communication skills
  • Excellent ability to follow GMP and SOP
  • Well-versed in cGMP requirements and has the ability to apply cGMP rules to the work-area
  • A logical and detailed oriented personality
  • Proven analytical and problem-solving skills
  • Must be familiar with overall pharmaceutical manufacturing/packaging and quality processes
  • Ability to work independently and manage multiple priorities in a fast-paced and changing environment
  • Strong organizational, time management and interpersonal skills
  • Proficiency with Microsoft Office (especially Word & Excel), Trackwise, Labware LIMS and SAP
  • Experience in project management and fluency in project management RCCA tools
• Experience
  •  3-5 years experience in a pharmaceutical environment