JO-2407-537392
Sterility Assurance Lead required this 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.
For a confidential discussion - contact Deirdre on 01 614 6178 or email an updated CV [email protected]
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 standard 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’s) qualification activities as per the guidance of Annex 1 for new and existing equipment that is 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.
- Coordinating on site aseptic processing and gowning training and implement 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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