Computer Systems Validation Group Leader

Date: Jun 3, 2022

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

 

  • 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 supervising and leading the routine operations of the validation and testing activities, including support to remote sites.
  • Responsible for all activities associated with the support of GIS Leadership in order that Apotex personnel can benefit from these efficiencies with minimal interruptions from CSV related activities.

 

Job Responsibilities

 

  • Lead cross-functional teams for validation programs required in implementation of computer applications for all supported sites.
  • Implement and maintain harmonized computer systems validation approach at Apotex sites.
  • Manage and lead continuous improvement initiatives.
  • Monitor the progress of projects/changes/initiatives to regulate validation resources requirement.
  • Handle day-to-day issues dealing with the activities of Computer Systems Validation group. Manage resources for Computer Systems Validation group.
  • Ensure that all assigned work plus work performed by direct reports is conducted in accordance with (c)GMP’s, SOP’s, GCP’s, regulatory requirements, best practices and established health & safety standards.
  • Develop, implement, and maintain Guidelines, Policies, Standard Procedures and tools to achieve a consistent approach to validate GxP Computer Systems in collaboration with other user groups.
  • Respond to the most complex and/or unconventional queries from executives, directors, managers, team members, other employees, and internal customers and provide policy interpretations, advice in their area of CSV expertise and functional business area experience, if appropriate. 
  • Support, coach, and motivate customers and stakeholders aligned to your area of responsibility, to ensure all equipment and processes within those areas are qualified using a consistent approach.
  • Ensure all timelines and commitments from the CSV team are achieved.
  • Assist GIS Leadership in implementing and monitoring progress against strategic plans to achieve the company goals and objectives.
  • Responsible for leading validation efforts for a given project as a key project team member and coordinate with other team members to ensure timely completion of related tasks.
  • Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
  • Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
  • Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
  • Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
  • Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
  • All other duties as assigned.

 

Job Requirements

  • Education
    • Minimum undergraduate degree in Science or Engineering required.
  • Knowledge, Skills and Abilities
    • Sound understanding of GMP’s and GAMP standards including validation process.
    • Excellent knowledge of FDA 21CFR Part 11 and other ER/ES 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 one of these: SAP, LIMS, Empower, LiveLink, Laboratory Systems, PLC Systems, Clinical Systems, Reg Affairs Systems.
    • Ability to understand and work with variety of Computerized Systems that are used for manufacturing and testing of drug products.
    • Excellent communication, interpersonal skills and presentation skills.
    • Excellent writing skills following Good Documentation Practices.
    • Excellent presentation skills in a variety of settings with business or technical users in small and large groups;
    • Excellent problem solving/trouble shooting skills.
    • Demonstrated ability to handle multiple work assignments.
  • Experience
    • 5+ years computer validation experience in health science industry.
    • 2+ years of supervisory/management experience in computer validation in health science industry.


 

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.