Executive/ Sr. Executive- Quality Assurance (Validation)

Experience: 3-7

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