IT Validation Specialist

1. OBJECTIFS DU POSTE / JOB OBJECTIVES

• Supervise, draft, plan, and execute various protocols to ensure the validation of all computerized systems, equipment, facilities, and processes in compliance with applicable standards and regulations
• Provide training and support to technologists on validation principles.

2. PRINCIPALES FONCTIONS / PRIMARY FUNCTIONS

• Draft, review, and approve validation protocols for software, equipment, systems, facilities, and processes related to computerized system validation activities.
• Draft and/or review change controls, non-conformance reports, procedures, and User Requirement Specifications (URS) associated with computerized systems.
• Ensure that validation protocols comply with the rationales, strategies, methodologies, and acceptance criteria defined by the department and regulatory authorities.
• Ensure data integrity in accordance with applicable regulations.
• Prepare periodic reviews of computerized systems.
• Coordinate and plan the execution of validation protocols.
• Analyze, compile results, and approve validation protocols and validation reports.
• Plan the use of internal resources and coordinate their activities to meet project timelines.
• Propose methods to improve departmental work processes.
• Provide technical support to other departments.
• Keep your superior informed of activities under their responsibility.
• Perform any other related tasks deemed relevant to the position.

3. EXIGENCES ET APTITUDES / EXPERIENCE REQUIREMENT AND APTITUDES

• Bachelor’s degree in engineering, Computer Science, or Sciences, or any other equivalent education
• 3–5 years of experience in the pharmaceutical industry or a related field.
• Experience with computer systems, equipment, production environments, and analytical laboratory instrumentation.
• Autonomous, organized, strong analytical skills, and leadership abilities.
• Excellent oral and written communication skills in both French and English (bilingual).
• Good knowledge of Canadian Good Manufacturing Practices (GMP) and international GMP standards.
• Ability to work effectively in a team.
• Solid knowledge of computerized systems.