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.

📌 QA Validation - Sr. Executive/ Assistant Manager (Ahmedabad)
🏢 Intas
📍 Ahmedabad