Analyst, Computer Systems Validation

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.
• Develop an in-depth understanding of all Apotex policies, processes, and standard operating procedures associated with their information technology area.
• Work 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
  • Understanding of GMP's and GAMP standards, including validation process.
  • 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.
  • Functional business area experience in using systems such as SAP, LIMS, Empower, PLC systems, Clinical systems etc.
  • Good communication and interpersonal skills.
• Experience
  • 2+ years Computer Systems Validation experience in health science industry.