Project Leader, Computer System Validation

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.