JO-2407-537392 Sterility Assurance Lead required for a Biotech manufacturing facility in Sligo town. Reporting to the QC Manager, this role demands a strong self-starter with a deep understanding of microbiology and associated risks in a biopharmaceutical EU GMP plant.
Role Ensure all microbiological practices comply with GMP and Department of Agriculture, Food and the Marine requirements, and any other relevant regulations.Conduct regular audits and inspections to maintain high standards of cleanliness and sterility and bioburden control.Design and implement robust environmental monitoring programs for the upgraded cleanrooms and new cleanroom areas.Analyze environmental monitoring data, identify trends, and take corrective actions as necessary.Lead aseptic process simulation (APS) qualification activities as per the guidance of Annex 1 for new and existing equipment required to support aseptic processing in the upgraded cleanrooms.Develop and execute aseptic process simulation validation protocols and generate comprehensive aseptic process simulation validation reports.Experience with validation and qualification of manufacturing equipment, HVAC systems, and other critical systems in a GMP environment.Support the project to upgrade cleanroom environments from Grade D to Grade A classification.Develop and implement a detailed action plan, including timelines, resource allocation, cost, and risk management strategies.Draft, review, and update SOPs related to microbiological practices, cleanroom operations, and environmental monitoring.Provide training on microbiological techniques, environmental monitoring, and GMP requirements.Train staff on new and updated SOPs to ensure consistent adherence.Coordinate on-site aseptic processing and gowning training and implement a routine requalification program.Implement and maintain effective contamination control strategies to prevent microbial contamination in the manufacturing process.Investigate and resolve microbiological deviations and non-conformities.Collaborate with Operations, Quality, Engineering, and TSA to ensure microbiological quality throughout the manufacturing process.
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