Validation Manager

The Validation Manager is responsible for overseeing and managing all validation activities within the pharmaceutical manufacturing facility. This includes equipment, utilities, processes, cleaning, and computerized systems to ensure compliance with regulatory requirements (FDA, EMA, ICH) and company standards. The role ensures that validation programs are effectively implemented, maintained, and continuously improved to support product quality and patient safety.

Key Responsibilities:

• Develop, implement, and maintain the site validation master plan (VMP).
• Lead and manage validation projects for equipment, processes, cleaning, and computerized systems.
• Ensure compliance with current Good Manufacturing Practices (cGMP), regulatory guidelines, and internal policies.
• Review and approve validation protocols, reports, and related documentation.
• Coordinate with cross-functional teams (Engineering, Production, Quality Control, IT) to ensure timely execution of validation activities.
• Manage risk assessments and change control processes related to validation.
• Provide training and guidance to staff on validation principles and procedures.
• Support regulatory inspections and audits by providing validation documentation and expertise.
• Monitor and report validation progress, issues, and metrics to senior management.