Technician, QAIP Pkg QS5-GQC-IPPSi S

Date: Jun 24, 2022

Location: North York, ON, CA, M9L 2Y6

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 on line review of batch documents and the inspection and physical testing on samples of packaged finished goods, to ensure that the in process products conform to established standards and regulatory requirements.

Job Responsibilities

  1. Ensure that individual work is performed and the Packaging department is operating in full compliance with GMP, SOD and established safety standards.
  2. Perform on-line batch document review for the applicable sections as per checklist.
  3. Notify QAIP and packaging personnel of any deviations found during the review of the in process batch documents. Ensure all corrections are made in the appropriate manner.
  4. Review in-process testing results and ensure tests were performed according to the required procedures and that all results are within the established specifications.
  5. Review in-process test results for completeness and provide immediate feedback to packaging technicians.
  6. Perform packaging line clearance per established procedures.
  7. Perform in process testing/inspection where required.
  8. Perform annual inspection of reserve samples and complete documentation according to established procedures.
  9. Collect laboratory, stability, and reserve samples, as required.
  10. Perform sampling, inspection and physical testing on in process/ investigational samples according to SOPs (if applicable).
  11. Report all deviations encountered during sampling and testing processes to the department Supervisor.
  12. Review logbooks for completeness and provide feedback to Packaging personnel, where applicable
  13. Assist packaging personnel with troubleshooting / investigation issues as required.
  14. Perform daily balance calibration.
  15. Where required, ensure equipment is calibrated before the calibration expiry according to established SOPs, and ensure that all results are properly documented and all calibration dates are current.
  16. 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;
  17. Works in a safe manner collaborating as a team member to achieve all outcomes.
  18. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  19. 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.
  20. All other relevant duties as assigned.

 

Job Requirements

  • Education: A college diploma/university degree in Pharmaceutical Technology/ Chemistry or related sciences
  • Knowledge, Skills and Abilities:
    • A good command of the English language, both written and verbal
    • Ability to follow instructions according to written procedures
    • Very good interpersonal skills required
    • A knowledge of GMP is an asset
    • Ability to work Night shifts when required
    • Familiarity with Word, Excel, Access is an asset
  • Experience:
    • 1-2 years of relevant working experience

 

 

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.