Computer Systems Validation Specialist

Date: Jul 5, 2022

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 training / mentoring / guiding team members on computer validation process. Take on a leadership role providing validation, compliance, and quality assurance expertise.

Responsible for leading validation effort for complex projects and issues as a key project team member and coordinate with other team members to ensure timely completion of related tasks.

Responsible for project planning, task assigning, prioritizing, executing, coordinating and maintaining qualification activities for Computerized Systems in accordance with regulations and defined Apotex quality standards, procedures and policies.

Responsible for assisting the department Associate Director in implementing and monitoring progress against strategic plans to achieve the company goals and objectives. May take on delegated tasks from the Associate Director from time to time related to CSV-Validation responsibilities.

Job Responsibilities

 

  • Ensure that all team members and relevant internal/external stakeholders are aware of current Apotex, association and government directives and enjoin team members and stakeholders from complying with these directives.
  • Serve as a senior validation, compliance, and quality specialist with Apotex’s management staff determining the tactical implementation of strategic requirements of the organization as per regulatory and compliance requirements.
  • Develop, recommend and implement/amend policies, procedures related and standards to CSV and information technology in support of validation program, quality standards, and regulatory compliance.
  • Provide advice, solution and respond to most complex and/or unconventional queries from executives, directors, managers, team members, other employees, internal customers, vendors.
  • Select and evaluate external suppliers and contractors for the provision of large technically specialized products and/or services.
  • Lead cross-functional project teams dealing with complex issues. Liaise with next level managers, keeping them current with new trends, regulations, compliance, and technology.
  • Develop an in-depth understanding of all Apotex policies, processes, and standard operating procedures associated with their information technology area.
  • Lead project tasks related to Computer Systems Validation in quality, laboratory, manufacturing, facilities, clinical, global enterprise systems and other functional areas.
  • Support and conduct vendor audits.
  • Support audit defense during internal and external audits for validation process of GxP impacting Computerized Systems.
  • Negotiate directly or oversee the resolution of the issues with customers, contractors, suppliers and other internal/external stakeholders.
  • Provide necessary training or conduct information session to effectively communicate the Validation program to project team members.
  • Perform and lead system risk and GxP impacting assessments.
  • Author validation documents such as validation protocols and reports as per defined in validation approach. Develop testing approach for system implementations.
  • Coordinate and manage test procedure authoring, execution, review and approval process. Coordinate execution of protocols and verify results.
  • Develop, execute, and lead remediation plans for existing systems to ensure compliance with applicable regulations.
  • Implement validation program as per corporate Validation Master Plan.
  • Develop and maintain procedures for ensuring that the systems are qualified before release to the business.
  • Support and lead departmental initiatives around Computer Systems Validation and Software Assurance.
  • Coach and mentor business users and the project team members on Computer Systems Validation and Software Assurance.
  • Perform periodic review of GxP impacting Computerized Systems.
  • Maintain and update records in the Computer System Registry as needed.
  • 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

 

  • Minimum undergraduate degree in Science or Engineering required.
  • Experience in the pharmaceutical industry is required for this role; 10+ years computer validation experience in health science industry would be a strong asset.
  • Excellent understanding of GMP’s and GAMP standards including validation process.
  • Excellent knowledge of FDA 21CFR Part 11 and other Electronic Records and Electronic Signatures regulations.
  • Experience with writing investigations and audit responses.
  • Experience with writing/executing validation protocols and reports for Computerized Systems.
  • Specialist in validation of systems in any three of the following computerized systems:
    • SAP
    • LIMS
    • Empower
    • Content Server
    • Quality Management System (QMS)
    • Learning Management System (LMS)
    • Manufacturing Execution System (MES)
    • QC Laboratory Software and Instrumentation
  • Excellent communication, interpersonal skills and presentation skills.
  • Excellent writing skills following Good Documentation Practices.
  • Demonstrated ability to make decisions, solve and troubleshoot problems based on analysis, experience and judgement.

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.