Associate, QA Validation II

Date: Jan 24, 2023

Location: Brantford, ON, CA, N3T 6B8

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

The Associate, QA Validation II Co-ordinates the process, cleaning and computer system validation program through the execution of the Master Validation Plan and monitoring progress of activities.

Job Responsibilities

  • Co-ordinates the process, cleaning and computer system validation programs, which includes
    • Execution of the Master Validation Plan by scheduling and coordinating the preparation and execution of the protocols, based on current production schedules. Depending on company needs, more focus may be applied to one or more projects at time.
    • Monitoring the progress of activities supporting the validation studies, compiling and preparing reports and maintaining summaries and indexes as required.
  • Provides guidance on validation relate matters and acts as a validation representative on interdepartmental teams as assigned and may also take on the role of project leader, where applicable.
  • Reviews and approves protocols and reports relating to the qualification of equipment, systems (such as utilities/computer) & facilities (DQ, IQ, OQ, PQ) and acts as a team member to provide regulatory guidance on ongoing projects, where applicable.
  • Assesses and approves devitaions/non conformances, trend data and proposed changes to processes (i.e., MBR changes), systems, equipment and facilities for impact on the validated status and provides recommendations for revalidation where necessary.
  • Prepares validation data summaries for Annual Product Reviews as well as other reports etc.
  • Reviews and approves documents, procedures, reports, certificates, etc., in accordance with SOPs and GMP standards for active pharmaceutical ingredients.
  • Contributes to the development of effective projects by assessing priorities, evaluating the various typs of documents required and ensuring appropriate training is provided and acts as project leader as assigned by management.
  • Reviews current and proposed regulatory guidelines and regulations and prepares summary and impact analysis reports for management review. As necessary, develops and acts implementation plans.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • 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.
  • All other relevant duties as assigned.

 

Job Requirements

  • Education
    • Education at University, or equivalent, level in a related scientific discipline.
  • Knowledge, Skills and Abilities
    • Practical validation experience and understanding of GMP regulations related to manufacturing equipment qualification and validation (process, cleaning and computer system) requirements in Canada, USA and International (ICH)
    • Effective and skilled communication (verbal and written) including good report writing, organizational and project management sklls.
    • Proficiency in computer applications and programs such as Word, Excel and Project Management related software
  • Experience
    • Minimum 5 years related experience in the Pharamceutical 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.