Overview To lead the Validation function, ensuring compliance with regulatory requirements and company standards for all validation activities.
This role owns the Validation Master Plan and related SOPs, oversees cleaning and process validation, and provides strategic and operational support for equipment, analytical instruments, utilities, and other validation requirements.
Responsibilities Lead and develop the Validation team to ensure high performance and engagement.
Allocate resources and prioritize validation activities to meet business and compliance objectives.
Own and maintain the Validation Master Plan (VMP) and ensure alignment with regulatory and company requirements.
Develop, review, and approve validation-related SOPs and ensure timely updates.
Ensure validation activities are planned, executed, and documented in compliance with GMP and internal standards.
Over process validation for new and existing products, including protocol development and execution.
Manage cleaning validation programs to ensure effective control of cross-contamination risks.
Coordinate validation of manufacturing equipment, analytical instruments, and utilities (e.g., HVAC, water systems).
Ensure timely execution and approval of validation protocols and reports.
Support technology transfers and new product introductions from a validation perspective.
Ensure validation documentation is audit-ready and supports regulatory inspections.
Address audit findings and implement corrective actions related to validation processes.
Implement best practices and maintain alignment with evolving regulatory expectations.
Requirements Degree in Engineering, Pharmaceutical Science, or related discipline.5+ years in validation within a GMP-regulated environment, with at least 2 years in a leadership role.
Strong experience in process, cleaning, equipment, and utilities validation.
In-depth knowledge of GMP and regulatory requirements for validation.
Excellent organizational and leadership skills.
Strong analytical and problem-solving abilities.
Ability to guide and motivate a team toward achieving validation objectives.
Commitment to maintaining high standards of regulatory compliance.
Strong understanding of validation principles and methodologies.
Ensures accuracy and completeness in validation documentation.
Works effectively across departments to support operational needs.
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