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Project Leader, QA Approver (One-Year Contract)

Date: May 11, 2021

Location: North York, ON, CA, M9L 1T9

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 and 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 deviation investigations at a site level and ensures investigations are initiated following existing procedures.
  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 root cause and CAPAs.
  11. Monitors root cause resolution for investigations through routine effectiveness checks.
  12. 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 preventive actions are appropriate for all complete investigations.
  13. As applicable, responsible for leading investigation of customer complaints.
  14. Immediately raises any concerns with departmental Manager and/or Site Senior Management, as required.
  15. Works in a safe manner collaborating as a team member to achieve all outcomes.
  16. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  17. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  18. All other relevant duties as assigned.

Job Requirements

  • Education: Bachelor of Science Degree
  • 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
    • Proficiency with Microsoft Office (Word & Excel), Trackwise, Labware LIMS and SAP
  • Experience:
    • 3-5 years of of experience in the pharmaceutical industry

 

 

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.

 

We have adapted our recruitment strategy to ensure our staff and applicants are safe by conducting our interviews and onboarding online.

Other measures Apotex has put into place include (but are not limited to):

•        staggering employee shifts to reduce the size of work groups

•        modifying our cafeteria space to enhance social distancing, the implementation of additional cleaning and sanitization routines

•        robust self-assessment and screening tools

•        non-surgical masks for employees working in GMP areas

•        travel restrictions

•        work-from-home policy for all employees who can perform their roles remotely

•        strict visitor screening protocol

It is important to note that while these are our protocols at this time, they are subject to change based on guidelines and regulations put in place by local and global government agencies.

For up-to-date information about Apotex’s ongoing efforts in response to COVID-19, visit: https://www1.apotex.com/global/covid-19-update or follow us on LinkedIn and Twitter