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Project Leader, Computer Systems Validation

Date: Jan 15, 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

Responsible for leading validation effort for a given project as a key project team member and coordinate with other team members to ensure timely completion of related tasks.
Responsible for planning, executing, coordinating and maintaining qualification activities for Computerized Systems in accordance with regulations and defined Apotex quality standards, procedures, policies.
 

Job Responsibilities

• 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 laboratory, manufacturing, facilities, clinical and other functional areas.
• Support vendor audits.
• Support audit defense during internal and external audits for validation process of GxP impacting Computerized Systems. 
• Demonstrate personal leadership attributes incorporating a commitment to ongoing professional development and continuous learning.
• 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.
• 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/ GIS Testing Methodology.
• Develop testing approach for system implementations.
• Develop and maintain procedures for ensuring that the systems are qualified before release to the business.
• Effectively communicate the validation activities and deliverables to the project team.
• Resolve directly issues with internal customers, contractors and other internal stakeholders.
• Support departmental initiatives around Computer Systems Validation and Testing.
• Coach and mentor business users and the project team members on Computer Systems Validation and Testing.
• 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

Education

•College Diploma / Bachelor degree in a related discipline.


Knowledge, Skills and Abilities

• Good understanding of GMP’s and GAMP standards including validation process.
• Sound knowledge of FDA 21 CFR Part 11 and other Electronic Records and Electronic Signatures regulations.
• Experience with writing/executing validation protocols and reports for Computerized Systems.
• Excellent communication and interpersonal skills.
• Excellent writing skills following Good Documentation Practices.

 

Experience

• 5+ years computer validation experience 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.