Purpose of the Job : - This position defines the responsibility for management of the validation program in factory - The validation program has been developed in accordance to Good Laboratory Practices (GLP) for non-clinical studies so as to assure corporate management that the operations and procedures are in conformance with Good Laboratory Practice regulations. - This incumbent is responsible for ensuring all equipment used in research or GLP related non-clinical studies are validated. - To establish and maintain a process that can ensure equipment are qualified or validated prior to use and maintain the status of the qualified equipment. - This position also includes responsibility for maintaining all documentation pertaining to qualification and validation and serves as an information resource for PMIRL-S staff, contractors, and vendors. Roles & Accountability : 1. Manage the organization''''s site-specific validation process, procedures and shared practices, which includes the development, implementation, maintenance and training and ensuring that they are in accordance with the external requirements such as GLP and the internal governing quality standards. 2. Provide technical support and guidance to system owners to develop validation-related documents such as specifications, as well as, execution of validation projects, including the reviewing and approving of the key set of validation documents to ensure compliance to internal process, procedures as well as external requirements. 3. Schedule and monitor timelines for qualification and validation activities in PMIRL-S and that they are executed in a timely manner whilst applying any relevant procedures and regulatory guidelines. 4. Maintain that the equipment / systems are in a ready validated state by reviewing of the validated state periodically; involve in change control process and ensuring that performance assessment for the equipment / systems are completed timely. 5. Review and approve validation deviations of equipment and systems and provide assistance in identifying the root cause and to implement corrective action in timely manner. 6. Interact with interdepartmental contacts on all validation-related activities such as deviation assessment, resolution and quality approval Implement and maintain the license management for facility. 7. Assist or interact with regulatory agencies as necessary. Must be able to effectively present documentation associated with validation. 8. Ensure that validation strategies, procedures are in place to anticipate and assure operational readiness and supporting any strategic or tactical planning for new facility start-up, process improvements and operational activities.