Associate Manager Quality Control (Microbiology)

Job description

Within this role you will manage the QC Microbiology team and provide critical microbiology support to manufacturing and facilities. A typical day might include, but is not limited to, the following: - Managing a team of laboratory analysts within the QC microbiology department involved in the analysis of raw materials, intermediates (in process) and bulk drug substance in a cGMP regulatory environment - Implementing and managing the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas - Managing QC microbiological operations to ensure compliance with cGMP standards and accurate sample analysis - Designing and overseeing microbiological validations as needed for drug substance, in-process controls and buffers - Managing the design, validation and execution of the clean utilities qualification and re-qualification program - Supporting manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed - Participating in the investigation and review of alert and action limit investigations as needed and...