ROLE
– Perform environmental monitoring sampling and quality analyses in manufacturing areas in accordance with established specifications and regulatory requirements.
– Interpret and evaluate environmental monitoring data for accuracy and precision against predetermined quality and regulatory standards.
– Identify ongoing quality issues related to environmental conditions and implement preventive measures to avoid potential contamination events.
– Operate various measuring devices and testing equipment using predetermined methods and prescribed specifications to assess environmental monitoring results.
– Audit and monitor environmental conditions and quality control processes against defined internal and regulatory standards.
– Test environmental samples from manufacturing areas to verify compliance with quality specifications and contamination control requirements.
– Report environmental monitoring deviations and out-of-specification results to relevant stakeholders in a timely manner.
– Contribute to process improvement initiatives by identifying opportunities to enhance environmental monitoring programs and methodologies.
– Maintain accurate and complete documentation of all environmental monitoring activities in compliance with GMP and GLP requirements.