Senior Executive - QA

Role & Responsibilities:
• Plan, prepare, review, and execute qualification protocols for plant equipment
• Coordinate and review all third-party calibration activities across the plant
• Review process validation protocols and ensure compliance with regulatory expectations
• Prepare and compile process validation reports with accurate data analysis
• Prepare qualification and validation protocols and reports for HVAC and Water Systems
• Conduct risk assessments for products and equipment
• Perform sampling and collection of validation samples
• Execute hold time studies including protocol preparation and sample collection
• Prepare and review Annual Product Review (APR) documentation
• Initiate, evaluate, and close change controls, CAPA, and risk assessments for products and equipment
• Handle and oversee cleaning validation activities
• Support audits and inspections related to validation and qualification

Qualification:
• B.Pharm or M.Sc from a recognized institution

Experience:
• 8-12 years of experience in Quality Assurance, Validation, and Qualification within the pharmaceutical industry

Skills:
• Equipment Qualification & Validation
• Process, Cleaning & Hold Time Validation
• HVAC & Water System Qualification
• Risk Assessment & CAPA Management
• Change Control & GMP Compliance
• Documentation & Regulatory Readiness
• Strong Analytical & Coordination Skills

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• About the Company:
  • Sun Pharma Laboratories Ltd is a leading global pharmaceutical company committed to quality, innovation, and compliance, offering a collaborative environment where employees grow, take ownership, and thrive together.