Systems Audit Support & IT Compliance Specialist

Date: Jul 28, 2022

Location: North York, ON, CA, M9L 1N7

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 Specialist, Systems Audit Support & IT Technical Compliance is responsible for providing IT compliance support for GMP systems during regulatory, internal corporate and customer inspections at Apotex Inc. In addition, this role will collaborate and support Apotex and the affiliate sites to ensure successful, compliant system implementations.

Job Responsibilities

 

  • In accordance with corporate established standards, perform IT Compliance audits of Apotex and affiliate sites, prepare reports and meet with management to review audit findings and, as necessary, assist in the investigation of audit findings to determine root cause and corrective/preventative actions.
  • Develop and maintain effective relationships with key GIS SMEs at Apotex and affiliate sites, QA and other internal departments in order to ensure timely audits, communication, and resolutions to discovered deficiencies and/or concerns.
  • Provide technical and regulatory guidance to internal IT infrastructure and application implementers to ensure regulatory compliance of computerized systems. Provide input on the development of computer validation testing to demonstrate adherence to established regulatory and internal requirements.
  • Participate in the development, implementation and maintenance of Enterprise Architecture standards for common GMP functions.
  • Provide information/insight on regulatory requirements and stay abreast of changes in regulatory environment/trends.
  • Provide IT SME support and logistics support during inspections of Apotex sites by regulatory agencies and customers. Follow up and compile information to support response and commitments made in the response to inspection reports.
  • Routinely examine published warning letters or observations given to other companies for IT compliance and challenge Apotex and affiliate sites against them.
  • Examine IT practices against SOPs to determine if SOP are existent, adequate or requires update.
  • 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
    • University or College degree in an Engineering or Science or Computer Science related program.
  • Knowledge, Skills and Abilities
    • Familiarity with regulatory requirements of electronic records for US, Canadian, European and other countries regulatory agencies, including Electronic Records and Electronic Signature regulations like 21CFR Part11 and Annex11.
    • Working knowledge of global guidance for data integrity.
    • Understanding of computerized systems as related to manufacturing, laboratory testing and clinical studies.
    • Excellent verbal/writing skills in relation to providing written responses and actions towards an observation.
    • Knowledge of computerized systems architecture, data structure, security structure, network topology and software interactions.
    • Knowledge in validation or testing requirements to be able to develop criteria for challenging systems against requirements.
  • Experience
    • Minimum 2 years experience in implementing systems with emphasis on data integrity.
    • Minimum 5 years experience in usage or implementation or validation of  computerized systems in a regulated industry (eg: GMP)

 

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.