About the role

Key Responsibilities

Plan, execute, and document validation activities including:
Process Validation
Equipment Qualification (DQ, IQ, OQ, PQ)
Cleaning Validation
Utility Validation (HVAC, Water Systems, Compressed Air)
Computer System Validation (CSV), if applicable
Prepare, review, and approve validation protocols, reports, and SOPs.
Ensure validation activities comply with cGMP, WHO, USFDA, EU-GMP guidelines.
Conduct risk assessments (FMEA, risk-based validation approaches).
Handle deviations, change controls, and CAPA related to validation.
Support internal and external audits and regulatory inspections.
Coordinate with Production, Engineering, QC, and IT teams for validation activities.
Maintain validation master plan (VMP) and ensure timely execution.
Ensure data integrity and documentation accuracy as per ALCOA principles.

Required QualificationsEducation:B.Pharm / M.Pharm / B.Sc / M.Sc / B.E / B.Tech (relevant discipline)Experience:2–6 years of experience in QA Validation (pharma/API/manufacturing)Freshers with strong validation knowledge may be considered for junior rolesSkills & CompetenciesStrong knowledge of GMP and validation principlesHands-on experience with validation documentationFamiliarity with regulatory guidelines (WHO, USFDA, EU-GMP)Good analytical, problem-solving, and communication skillsAbility to work independently and in cross-functional teamsProficiency in MS Office and documentation practices

Executive/ Sr. Executive- Quality Assurance (Validation)

About the role

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