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, Freezer...