QA Validation - Sr. Executive/ Assistant Manager

Role & responsibilities

• Review and approve Equipment & Facility Qualification documents.
• Review periodic equipment performance verification protocols and reports.
• Support qualification, calibration, and preventive maintenance activities.
• Track calibration, validation, and qualification schedules.
• Monitor and follow up on OOL, CAPA, deviations, change controls, risk assessments, and malfunctions.
• Review and approve SOPs and engineering-related SAP updates.
• Prepare and review HVAC HEPA filter validation reports.
• Monitor Environmental & Water System trends and prepare annual summaries.
• Prepare, review, and approve qualification and validation protocols/reports.
• Review SOPs and records related to P&A and EHS.
• Maintain and monitor quality documentation and apex documents.
• Ensure compliance with GMP, GDP, GxP, and Data Integrity requirements.
• Review records and reports for Data Integrity compliance.
• Handle potential Data Integrity observations as per SOP.
• Perform additional responsibilities assigned by the supervisor.