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Role Summary: Reporting to the QC Manager, The Site Microbiologist is responsibly for ensuring all site Microbiological activities are carried out in compliance with product licence commitments, cGMP and company Quality standards. The site microbiologist will provide technical expertise and front-line support to the Sterility Assurance, QC, Engineering & and Business Unit teams. This assignment is covering a maternity backfill assignment.
• Provide support to the site Sterility Assurance Group • This role is responsible for assisting the sterility assurance specialist in setting the standards and systems for bio-burden and its control. • Ensuring that the bio-burden data is accurate and representative and that the process is adequately assessed and documented. • Ensuring that the Biological Indicator validation is accurate and fully compliant with the sterilization monograph and site procedures including proper storage, assessment, use and measurement of the BI’s used in the validation process • Assessment/ approval of changes with regard to sterility assurance/ bioburden control systems in conjunction with the sterility assurance specialist. • Provide leadership and direction in all areas relating to the sterility assurance of the product. • Ensure clear communication to all stakeholders and customers. • Ensure systems are in place to such that all site microbiological activities are carried out in compliance with product license commitments, cGMP and Quality standards. • To lead all microbiological discussions during regulatory inspections and internal audits • Anticipate and plan for future requirements within remit, including such aspects as procedural requirements, compliance requirements, efficiency developments and anticipated changes needed to reflect future demand for services from the departments • Ensure safe practices are adhered to at all times in the laboratory. • Identify and support training needs required for the site and the QC team. • Ensure clear and measurable goals are set in a timely manner for both QC and BU teams. • To take the responsibility to engage employees to enable the delivery of the departments functional goals including financial and people development. • Provide support to, and deputize for, the QC Manager as required • Provide support to the QC Management team as required • Foster an environment of continuous improvement and providing leadership in this area by identifying and implementing practices to deliver efficiency, cost reduction, quality and service level improvements across the site. • Responsible for the QC Technical Support & Release Team • Support the development of the deputy site microbiologist role and work with these personnel to develop and implement continuous improvement projects from a microbiological perspective • Provide support and technical expertise to the site to ensure people and technical skills are in place to implement new technologies and apply best practice in Microbiological techniques and systems. • To ensure that all company policies are adhered to by self.
• Primary degree in Science essential supported by a sound technical background in Microbiology or equivalent knowledge and experience . • Proven years microbiology expertise in a regulated Pharmaceutical industry essential • Excellent interpersonal and communication skills with good leadership abilities. • Experience of direct interaction with Regulatory Bodies (e.g. HPRA, FDA) desirable
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