Q&V Coordinator - Quality

About the role

The Q&V Coordinator - Quality role at ACG Capsules in Dahanu, India, is responsible for executing the Validation Master Plan (VMP) and managing qualification and validation activities for equipment, instruments, and areas. Day-to-day work includes preparing and approving protocols, participating in IQ/OQ/PQ execution, collaborating with engineering and calibration teams using SAP, supporting DMS implementation, and reporting monthly status. The coordinator also trains associates on validation concepts and holds authorities for QMS document approvals and final batch release.

What you’ll do

• Prepare Validation master plan annually and ensure adherence to schedule for qualification and validation of equipment, instruments, and areas
• Prepare and get protocols reviewed and approved prior to execution of Validation activities
• Participate in validation and qualification as per the approved protocol
• Work with the user department to list observations as per the approved and executed protocol
• Share conclusions from Validation/Qualification with the QA/Quality Head
• Work with the Engineering Team and Calibration team with compliance using SAP
• Support the DMS system implementation across the plant
• Conduct training for Management associates and Plant associates on Validation and Qualification

What you’ll bring

• Ability to prepare and execute Validation Master Plan (VMP) annually
• Experience in preparing, reviewing, and approving qualification and validation protocols
• Knowledge of IQ/OQ/PQ qualification processes for machines, instruments, and equipment
• Familiarity with SAP for compliance and data entry
• Experience supporting Document Management System (DMS) implementation
• Understanding of QMS documents such as change control, deviation, OOS, and investigations
• Ability to train Management and Plant associates on validation and qualification concepts
• Capability to prepare monthly status reports and maintain schedule adherence

Skills