Key Responsibilities

• Supervise pre-use and post-use filter integrity testing activities as per approved procedures.
• Ensure proper execution of filtration operations and compliance with validated processes.
• Monitor and review filter integrity test results, batch records, and logbook entries.
• Verify the installation, usage, and replacement of filters as per approved specifications.
• Ensure compliance with GMP, GDP, SOPs, and data integrity requirements.
• Investigate filter failures, deviations, and out-of-limit results, and support CAPA implementation.
• Coordinate with QA, Engineering, Validation, and Production teams for smooth operations.
• Ensure filtration equipment and integrity testing instruments are maintained and calibrated.
• Review and approve operational documentation related to filtration activities.
• Train and guide operators on filter handling, integrity testing procedures, and documentation practices.
• Monitor shift activities and manpower utilization to meet production schedules.
• Ensure adherence to safety, hygiene, and housekeeping standards in the production area.