Cache of job #13535405

Job Title

Plant Microbiologist

Employer

Pe Global

Location

Cork

Description

PE Global are currently recruiting a Plant Microbiologist for our Client based in Cork. This is a Permanent role. Please call Catherine on 0214297900 for more information. Purpose of the role: This position will report to the QC Manager. The successful candidate is responsible for ensuring all site microbiological activities are carried out in compliance with product license 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. Responsibilities of the role: •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, 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 regards 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. •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. Education and Experience Required. Primary degree in Science essential. Background in Microbiology. At least 5 year’s experience in a similar role or environment. Previous project experience within a pharmaceutical or regulated industry. A strong working knowledge of Utilities and Facilities systems with relation to microbiology. If you are interested in this position, please send your CV to catherine.osullivan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

Date Added

2774 days ago

Apply