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Your Role
Identify, plan, and implement validation requirements across equipment, instruments, utilities, and manufacturing/testing processes in a cGMP greenfield facility.
Prepare and execute IQ/OQ/PQ protocols; coordinate and support cleanroom qualification, facility and utility qualification activities; create and govern the Validation Master Plan (VMP); review, approve, and maintain validation protocols, SOPs, and technical documentation in a controlled, compliant manner (cGMP, GAMP 5, FDA 21 CFR Part 11, ISO 9001).
Identify and assess validation changes, deviations,



and CAPAs; ensure remediation and closure of compliance actions; conduct risk assessments (FMEA, impact assessments); perform trend analysis of non-conformances and data reviews; ensure QMS conforms to ISO 9001a and organisational policies; lead audits and regulatory inspections; drive root cause analysis and timely closure of corrective actions; collaborate with cross-functional teams to drive validation deliverables.
Acts as the quality face to customers for products; performs process audits to identify gaps and implement corrective actions; supports technology transfer and global projects; stays current with industry regulations and trends; supports EHS/OSHA as required; operates in a multi-cultural, multi-time-zone workplace; demonstrates robust networking and problem-solving skills to influence across organizational levels.
Strategic objective: build a solid Validation Team to enable

📌 Validation And Qa Specialist 1 Bengaluru (India)
🏢 Merck Life Science
📍 India