Execute qualification, validation, and cleaning validation activities in compliance with the Validation Master Plan (VMP), cGMP requirements, and company standards.
Prepare, review, and maintain qualification and validation protocols, reports, and associated documentation (DQ, IQ, OQ, PQ, PPV, and Mapping).
Coordinate validation and qualification activities with cross-functional departments and external vendors.
Manage validation-related change controls and ensure timely review, approval, and closure.
Maintain validation schedules, including process validation, cleaning validation, and temperature mapping programs.
Ensure proper control, archival, and retrieval of validation, quality, and manufacturing documents.
Develop, review, and update validation-related SOPs and quality documentation.
Support computerized system compliance, including data integrity, backup and recovery, business continuity, and information security requirements.
Conduct training on validation, SOPs, and cGMP requirements while promoting continuous audit readiness.
Provide technical and operational QA support, including SAP master recipe management, IPQA activities, and other duties assigned by management.