Validation Supervisor

JOB OBJECTIVES
Ensure compliance, scientific rigour and efficiency in the validation of processes, equipment/system,
cleaning and computerised systems, in accordance with regulatory requirements (GMP, FDA, EMA,
HC, etc.) and company quality standards.

PRIMARY FUNCTIONS
• Supervise the team of validation specialists (participate in recruitment, manage performance,
conduct performance reviews, etc.).
• Ensure compliance, scientific rigour and efficiency in the validation of processes, equipment,
computerised systems and analytical methods, in accordance with regulatory requirements (GMP,
FDA, EMA, HCC, etc.) and company quality standards.
• Technical supervision: Lead a team of validation specialists (processes, equipment, cleaning,
computerised systems) and ensure their skills development.
• Regulatory compliance: Supervise validations in accordance with GMP, FDA 21 CFR Part 11,
ICH Q7/Q9/Q10, and internal SOPs.
• Validation project management: Plan, coordinate, and monitor validation activities as part of
commissioning, technology transfer, or equipment change projects.
• Quality documentation: Approve protocols, reports, traceability matrices, and ensure their
compliant archiving.
• Audit and inspection: Prepare and support internal and external audits (FDA, EMA, Health Canada,
etc.), ensuring the traceability and robustness of validations.
• Continuous improvement: Identify opportunities to optimise validation processes (reduction of
lead times, digitisation, standardisation).
• Regulatory and technological monitoring: Stay informed of regulatory and technological
developments in order to adapt validation practices.
• Establish and monitor KPIs to measure validation performance (compliance rates, deadlines,
incidents).
• Replace the Validation Head as required.
• Develop, review and implement a compliant and cost-effective validation strategy for the plant
(VMP, CVMP, CSVMP.
• Plan and review validation activities.
• Provide operational support on technical issues, projects and timelines for planned validation
activities.
• Perform any other related tasks deemed relevant to the role