Executive - Equipment Qualification, MS&T

Workplace Type

Full-time

Job ID: IJOB202664549

• Prepare and review User Requirement Specifications (URS) for facilities, utilities, systems, and equipment in compliance with cGMP, regulatory, and quality requirements.
• Plan and execute qualification activities for facilities, HVAC, cleanrooms, utilities (Purified Water, Compressed Air, Nitrogen, Steam), process equipment, and laboratory instruments as per the Validation Master Plan (VMP).
• Develop and implement IQ, OQ, and PQ protocols, reports, and supporting documentation to ensure compliance and audit readiness.
• Conduct risk and impact assessments to define qualification scope for new, modified, and existing systems.
• Perform periodic requalification and performance verification to maintain validated system status.
• Coordinate with Engineering, Production, QA, QC, R&D, and Maintenance for effective qualification planning and execution.
• Ensure data integrity and maintain complete qualification records throughout the validation lifecycle.
• Support deviation investigations, Change Control, and CAPA related to qualified systems.
• Drive continuous improvement of qualification and validation practices in line with current regulatory requirements and industry best practices.