Location: Cork Role: Permanent
To ensure 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 Production and Packaging Platforms.
• 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 the bio-burden data is accurate and representative and the process is adequately assessed and documented.
• Ensure that the Biological Indicator validation is accurate and fully compliant with the sterilisation monograph and site procedures including proper storage, assessment, use and measurement of the BI’s used in the validation process.
• Assessment/ approval of changes relating 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 licence commitments, cGMP and Quality standards.
• 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
• 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 Platform teams.
• Primary degree in Science essential supported by a sound technical background in Microbiology.
• Min 5 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)