Job description preview
From GSK’s original posting
Act as the site microbiology subject matter expert; provide microbiologist expertise and develop monitoring strategy and operation framework. Ensure that all site utilities, water, environmental monitoring, and product testing activities are properly analysed and executed, and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards. Key Responsibilities • Ensures that all water, environmental monitoring, site utilities and product testing samples are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. Develops a strategy for the site with respect to environmental monitoring and water systems. Perform microbiological risk assessment for all non-sterile products • Ensures that external service providers and suppliers for microbiology laboratory are managed in accordance to GSK requirements • Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME). Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology…
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