Key Responsibilities

• Execute and monitor validation activities for sterile injectable manufacturing processes.
• Prepare, review, and maintain validation protocols and reports.
• Perform qualification activities including:
  • DQ, IQ, OQ, and PQ for equipment and utilities
  • HVAC validation
  • Water system validation
  • Compressed air and nitrogen validation
• Coordinate process validation and media fill activities.
• Perform cleaning validation and hold time studies.
• Ensure compliance with cGMP, SOPs, and regulatory guidelines.
• Review validation documentation and ensure proper data integrity practices.
• Coordinate with Production, Engineering, QC, and Microbiology departments.
• Handle deviations, change controls, CAPA, and risk assessments related to validation.
• Support internal audits and regulatory inspections.
• Maintain validation master plans and schedules.