Executive / Sr. Executive- Quality Assurance (Validation)

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 Qualifications Education: 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 roles Skills & Competencies Strong knowledge of GMP and validation principles Hands-on experience with validation documentation Familiarity with regulatory guidelines (WHO, USFDA, EU-GMP) Good analytical, problem-solving, and communication skills Ability to work independently and in cross-functional teams Proficiency in MS Office and documentation practices