Key Responsibilities

• Perform and supervise pre-use and post-use filter integrity testing (FIT) as per approved SOPs and validation requirements.
• Ensure proper installation, operation, and handling of filters used in manufacturing processes.
• Monitor and verify integrity test parameters, results, and acceptance criteria.
• Maintain accurate records, logbooks, and documentation related to filter integrity activities.
• Coordinate with Production, QA, QC, and Engineering teams for filter management and production support.
• Investigate deviations, out-of-specification results, and integrity test failures, and participate in root cause analysis.
• Ensure compliance with cGMP, GDP, data integrity, and regulatory requirements.
• Support qualification, validation, and revalidation activities related to filtration systems.
• Monitor inventory and lifecycle management of filters and associated consumables.
• Participate in internal audits, regulatory inspections, and continuous improvement initiatives.
• Ensure adherence to safety, housekeeping, and contamination control practices.