Responsible for ensuring compliance of defined procedures for team function. Review / Approval of QMS elements (Deviation, Change control, CAPA) in IT enabled applications (Trackwise, Documentum, etc.) to ensure adequacy, completeness and timely closure of records. Facilitating and ensuring of validations and Qualifications. Ensuring the compliance for IPQA activities. Supervising and ensuring Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per GxP GLP, GMP, GDP, cGMP FDA Assessment. Supervise and ensure document control activities like issuance, retrieval, storage and destruction as and when require. Ensure to perform and facilitate the execution of relevant protocol such as process/personnel qualifications, process validation, cleaning validation, transport validation in compliance to the requirements specified in the protocols and associated documents including current procedures. Ensuring review and completion of executed documents. Responsible to conduct audit to maintain cGMP & their compliance at all levels. Facilitate and ensure quality work culture for colleagues and develop the competencies of colleagues.