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Project Leader - QA Approver

Date: Jan 15, 2022

Location: Etobicoke, ON, CA, M9W 6Y3

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

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/investigate deviations are followed and appropriate corrective actions / preventative actions (CAPA) are identified and implemented.

Job Responsibilities

  1. Oversees and acts as Quality Approver and SME for Apotex OSD Investigations (Production, Production Technical, In-process, Customer Complaints failures) at a site level and ensures investigations are initiated following existing procedure(s).
  2. Acts as resource providing support and guidance to Lead Investigators.
  3. Reviews and approves initiated Investigation Problem Statements and Immediate Action / Impact Assessment sections of investigation drafted by Lead Investigators.
  4. Meets with Lead Investigators to discuss deviation and provide direction into development of the investigational plan.
  5. Reviews and approves the Investigation Plans submitted by Lead Investigators.
  6. Ensures that investigations identify the root cause and the impact is assessed and the corrective & preventative actions are appropriate for all complete investigations.
  7. 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.
  8. Reviews the on-going progress of open investigations with Lead Investigators and provide guidance as required.
  9. 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.
  10. 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.
  11. Monitors root cause resolution for investigations through routine effectiveness checks.
  12. Approves Production and Production Technical, In-process and Customer Complaint investigations at a site level for Apotex OSD.
  13. Immediately raises any concerns with departmental Manager and/or Site Senior Management, if required.
  14. Revises existing procedures as necessary.
  15. Works as a member of a team to achieve all outcomes.
  16. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
  17. Performs all work in accordance with all established regulatory and compliance and safety requirements.
  18. All other 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

 

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements.  Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada.  Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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.