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.