Senior Officer/Executive

Key Responsibilities

• Prepare and review process validation and cleaning validation protocols and reports
• Review BPCR, BPR, PCOCR, SDR, and BLR documents to ensure compliance and completeness
• Handle hold time studies and stability activities for products
• Prepare Annual Product Quality Review (APQR) for regulatory and internal requirements
• Conduct utility qualification for HVAC systems, water systems, nitrogen systems, and air compressors
• Execute Quality Management System (QMS) activities, ensuring adherence to SOPs
• Prepare and review SOPs related to QA and manufacturing processes
• Maintain accurate documentation for audits, inspections, and regulatory submissions
• Support cross-functional teams in implementing corrective and preventive actions