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 and instruments, executing initial qualification deliverables: installation qualification, operational qualification, and performance qualification.
• Responsible for equipment qualification of pharmaceutical equipment in quality control, e.g., sterility isolators, biosafety cabinets, incubators, freezers and refrigerators.
• Responsibl...