Lead and execute validation and qualification activities for manufacturing processes, equipment, and systems in compliance with internal and external standards.
Develop, review, and approve validation protocols, reports, and related documentation to ensure accuracy and regulatory compliance.
Coordinate and oversee the execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment.
Collaborate with cross-functional teams including production, quality assurance, and engineering to ensure seamless validation processes.
Identify process improvements and implement best practices to enhance validation efficiency and effectiveness.
Ensure all validation activities are conducted according to Good Manufacturing Practices (GMP) and relevant regulatory requirements.
Maintain comprehensive records of validation and qualification activities for audit readiness.
Train and mentor junior staff on validation procedures and compliance standards.
Participate in internal and external audits, providing expertise on validation and qualification matters.
Stay updated on industry trends, regulatory changes, and technological advancements related to validation and qualification.