Amneal Pharmaceuticals - Manager - Validation Quality Assurance

JOB DESCRIPTION :

Essential Functions :

• Prepare and review Validation Master Plan (VMP) in alignment with site validation strategy and regulatory requirements.
• Monitor and review qualifications of equipment, systems, and utilities, including HVAC, purified water, and compressed air systems.
• Oversee and support process validation activities including protocol preparation, execution, data compilation, and report finalization.
• Review validation protocols and reports for equipment, cleaning, facility, utility, and computerized systems.
• Ensure validation lifecycle management and periodic re-validation as per established schedule.
• Initiate and review change controls, deviations, CAPAs related to validation activities.
• Conduct and support failure investigations and implement robust corrective / preventive actions.
• Ensure adherence to regulatory expectations (USFDA, EU, WHO, etc.) in all validation activities.
• Maintain all validation documentation as per data integrity and Good Documentation Practices (GDP).
• Ensure timely execution and review of cleaning validation and verification activities.
• Participate in risk assessment (FMEA, HAZOP) and quality risk management related to validation.
• Train QA and production personnel on validation concepts and GMP requirements.
• Coordinate with cross-functional teams (Engineering, Production, QC, IT) to ensure validation readiness.
• Participate in regulatory, internal, and third-party audits as validation SME (Subject Matter Expert).

Additional Responsibilities :

M. Pharm - 10 to 15 years of relevant experience in Validation QA in pharmaceutical / API / Formulation manufacturing.

(ref : iimjobs.com)