Opportunity 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...