Job Description

Sr. Specialist Quality – Manufacturing Science & Technology Job Role Summary Responsible for the end-to-end qualification and validation (IQ/OQ/PQ) of pharmaceutical laboratory equipment, utilities (HVAC/Water), and computerized systems. Ensures strict compliance with regulatory standards, including GAMP5, 21 CFR Part 11, and data integrity guidelines. Manages validation lifecycles, temperature mapping, CSV deliverables, and associated Quality Management System (QMS) processes (deviations, change controls, CAPAs). 
Responsibilities Responsible for Qualification of Quality control Equipment’s and instruments. Executing the Qualification deliverables for initial Qualification i.e Installation Qualification, Operational Qualification & performance Qualification. 
Responsible for the Equipment Qualification pharmaceutical Equipment’s Quality control (for Examples: Sterility isolators, Bio Safety Cabinets, Incubators, Freezers and Re...
            

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