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 recent 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."