Senior Executive - QA Validation

Roles & Responsibilities
• Plan, execute, and document Process Validation (PV), Cleaning Validation (CV), and Re-validation activities for injectable products
• Prepare and review validation protocols and reports including IQ, OQ, and PQ
• Perform equipment validation for autoclaves, depyrogenation tunnels, sterilizers, vial washing machines, filling lines, and lyophilizers
• Conduct qualification of utilities including WFI systems, pure steam, HVAC, and compressed air
• Execute and evaluate Media Fill (Aseptic Process Simulation) studies to ensure sterility assurance
• Develop cleaning validation strategies including worst-case product selection and changeover validation
• Perform swab and rinse sampling and evaluate results
• Prepare and maintain Validation Master Plan (VMP), risk assessments (FMEA, QRM), and validation-related SOPs
• Ensure compliance with cGMP, WHO, USFDA, EU-GMP (Annex 1) requirements
• Investigate validation deviations and implement CAPA
• Participate in change control and impact assessments
• Support regulatory and customer audits and present validation documentation to inspectors
• Coordinate with Production, QC, Engineering, and QA teams for validation execution
• Train manufacturing personnel on validation procedures and compliance requirements

Qualification
• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy)

Experience
• 4–6 years of experience in QA Validation within sterile injectable manufacturing
• Strong exposure to equipment qualification, aseptic validation, and regulatory inspections
• Internal applicants must have completed at least 2 years in their current role

Skills
• Proficiency in Process Validation, Cleaning Validation, and Equipment Qualification
• Strong knowledge of aseptic processing and sterile manufacturing
• Expertise in autoclave validation, HVAC validation, media fill validation, lyophilizer qualification, and WFI system qualification
• Advanced understanding of EU-GMP Annex 1, USFDA, WHO, and PIC/S guidelines
• Strong knowledge of ALCOA+ data integrity principles
• Proficiency in sampling techniques (swab & rinse)
• Expertise in risk assessment tools such as FMEA, HACCP, and QRM
• Strong documentation, analytical, and audit-handling skills

About the Organization
Amneal Pharmaceuticals Pvt. Ltd. is a leading global pharmaceutical company engaged in the development, manufacturing, and distribution of high-quality generic and specialty medicines. With advanced manufacturing facilities and strong regulatory compliance across global markets, Amneal Pharmaceuticals offers robust career opportunities in sterile injectables, operations, engineering, and quality systems.