Clean Room Monitoring: Ensure that the clean room environment complies with ISO 14644 standards and other relevant industry regulations. Conduct regular environmental monitoring, including air quality, particulate control, and sterility.
Good Manufacturing Practices (GMP): Ensure that all procedures adhere to GMP standards, focusing on contamination control and maintaining product integrity throughout production.
Quality Audits & Inspections: Prepare and participate in internal and external quality audits, including FDA, ISO, and other regulatory bodies.
Process Validation: Oversee validation activities, including equipment qualification (IQ, OQ, PQ), process validation, and ensuring that all clean room operations meet regulatory standards.
Documentation & Reporting: Maintain detailed documentation, including standard operating procedures (SOPs), batch records, and audit trails. Ensure all records comply with industry and regulatory requirements.
CAPA (Corrective and Preventive Actions): Investigate quality issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA) to resolve non-conformances and prevent future occurrences.
Training & Compliance: Train clean room personnel on best practices and compliance protocols, ensuring adherence to contamination control, sterility, and GMP.
Risk Management: Identify potential risks in clean room processes and implement strategies to mitigate contamination and ensure product safety.
Continuous Improvement: Work with cross-functional teams to drive improvements in clean room processes, quality standards, and operational efficiency

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qa/qc clean room.

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