Essential Duties and Responsibilities:
? Ensure product quality meets established standards and policies.
? Conduct thorough environmental monitoring during production and prepare detailed reports, proposing solutions for any issues.
? Perform on-site monitoring of production areas, testing, and cell banking.
? Inspect incoming raw materials and conduct sampling for quality control testing.
? Develop, update, and revise Standard Operating Procedures (SOPs) and documentation related to facilities management.
? Provides information on equipment maintenance, calibration, SOPs, and GMPs as needed.
? Conduct regular inspections of facilities, utilities, and equipment to ensure they are functioning properly and in compliance with established standards and regulations.
? Monitors environmental and equipment parameters through the Building Management System (BMS) & Environmental Management System (EMS).
? Respond to and troubleshoot any emergencies, interruptions, or out-of-specification incidents related to facilities, utilities, or equipment.
? Review process control plans and drive continuous improvement and quality achievements.
? Investigate deviations and non-conformance incidents, ensuring timely and effective corrective measures.
? Compile documentation for quality evaluation and product release.
? Support product recall procedures and handle recalled products appropriately.
? Assist in adverse reaction reports investigation and patient complaint reviews.
? Assist in internal audits, external audits and follow up on corrective actions.
? Assist in budget planning and management for operations, maintenance, and improvement projects.
? Assist with planned validation activities in the laboratory.
? Assist in training and guidance to junior staff members to ensure proper procedures and practices are followed.
? Compile information and issues for quality communication meetings.
? Collaborates with team members and other departments within the organization.
? Promote a positive work environment through effective communication.
? Performs other assigned duties as required to meet company objectives.