Title:  Sr. Specialist

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 Refrigerator etc.).
• Responsible for the Utilities Qualification (HVAC and Water System, Sterility QC lab).
• Preparation and review of validation deliverables like User Requirements Specification (URS), Quality Risk assessment (QRA), GxP assessment, Functional Requirement Specification, DS, FRA, IQ, OQ, PQ, Design traceability Matrix, and summary validation Report etc.
• Responsible for the temperature mapping of Cold Stores, Incubators, Sample Storage Area & Temperature Controller Chambers.
• Responsible for executing validation activities for GxP and computerized systems like Systems in accordance to the GAMP5 Validation Life Cycle for the Equipment’s. etc.
• Responsible for maintaining the User Access management for the QC lab instruments.
• Responsible for performing the Qualification of QC lab instruments HPLC, GC, UV and aware of 21 CFR part 11 complaint requirements.
• Responsible for preparation, review and closure of test incidents/defects and status reporting.
• Perform periodic review or Re-qualification of the Equipment’s & GxP systems to ensure that they continue to remain validated.
• Work with area owner(s) to ensure the initiation and implementation of scheduled activities for the Qualification.
• Handling of Validation system related QMS like deviations, change controls and CAPA’s etc. Responsible for management for validation documents like archiving, retrieving and distribution.

Qualification & Experience: