QA-SME

Hyderabad, India April 16, 2026 Full Time Workday

Job Description:

ITQA / CSV:

Experience with CSV, US FDA 21 CFR Part 11, EU Annex 11, GAMP 5
Strong background in pharma industry validation (GLP/GMP environments)
Ability to develop validation documentation: plans, specifications, test protocols, SOPs
Exposure to Process Automation, Laboratory Automation, Enterprise IT Applications, Network Infrastructure
Knowledge of V-Model, SDLC Lifecycle, SOPs
Hands-on with SCA, URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR,
Traceability Matrix, FRA/FEMA
Experience with QMS tools & Regulatory Audits
Knowledge about GMP, Data integrity, digital remediation.
Preferred: Agile Development experience
Tools: Trackwise, ServiceNow, LMS, Veeva Vault, EDMS

Ferring India Laboratories

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