Loading...

Computer Systems Validation Analyst

Date: Dec 26, 2020

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

Job Responsibilities

 

  • Perform system risk and GxP impacting assessment.
  • Author validation documents such as validation protocols and reports, as per the defined validation approach.
  • Coordinate and manage test procedure authoring, execution, review and approval process. Coordinate execution of protocols and verify results.
  • Develop and execute remediation plans for existing systems to ensure compliance with applicable regulations.
  • Implement validation programs 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.

Job Requirements

 

  • College Diploma or Bachelor degree in a related discipline
  • 1-2 years experience with Computer Systems Validation is required for this role
  • Experience with audits, data integrity assurance, electronic records/electronic signature regulations, computer system validation testing, lab system implementation, user requirement collection, test executions and authoring and experience in health science industry would be highly preferred
  • Understanding of GMPs and GAMP standards, including validation process, knowledge of FDA 21 CFR Part 11 and other Electronic Records and Electronic Signatures regulations would be a definite asset
  • Functional business area experience in using systems such as SAP, LIMS, Empower, PLC systems, Laboratory systems would be preferred

 

 

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.