Job responsibility. "• To ensure cGMP compliance at shop floor during manufacturing of vaccines and bio similar. • Preparation, Execution and compilation of validation activities pertaining to: • Qualification (IQ, OQ and PQ) of new equipments and Utilities (such as Water System, HVAC System, Pure Steam, Compressed Air). • Periodic re-qualification of existing equipments and critical systems. • Area Qualification. • Coordination with External service provider for Execution of Qualification activity. • Coordination for execution of CAPA plan/risk mitigation plan, shutdown and to ensure implementation of corrective and preventive action related to qualification activity • Execution and compilation of reports of planner pertaining to qualification/validation and calibration / preventive maintenance activities as per established schedule. • Maintain qualification document with proper filing and retrieval of same as and when. • Preparation of Purchase Indent. • To initiate change control and prepare documents related to qualification activity. • To prepare and follow Annual validation Planner. • Preparation/revision of SOP’s related to Qualification & Validation and validation master plan • Report any non-conformance to In-charge/ HOD /Designee if any."