Site Microbiologist - County Waterford, County Waterford, Icds Recruitment Consultants Ltd

Ireland, Ireland, County Waterford
Published 2023-03-18
Expires 2023-04-18
ID #1448992404
Site Microbiologist - County Waterford, County Waterford, Icds Recruitment Consultants Ltd
Ireland, Ireland, County Waterford,
Published March 18, 2023

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Site microbiologist - county waterford

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Site Microbiologist - County Waterford. In this role you will be responsible for the micro/bioburden and environmental monitoring (EM) management program. The main duties of the role include performing monthly environmental monitoring in accordance with cGMP principles, managing micro-excursion events internally and with the customer, micro-data analysis and reporting, as well as supporting and leading GMP training activities in relation to bioburden. Acts as quality contact for all micro/bioburden issues at the site. Key Responsibilities: • Creates/maintains all site procedures in relation to micro/EM • Understands and executes risk management practices in relation to EM. • Identifies, investigates and manages the resolution of excursions in bioburden/micro at the site. • Proactive in the prevention of excursions in bioburden/micro at the site • Communicate excursions in bioburden/micro to the site Quality Lead. • Generates annual EM summary report. • Exposure and involvement in supporting the CAPA system. • Complete appropriate reports in relation to microbiology activity performed at the site. • Support the company with internal and external audits. • Develop and manage microbiological and cleanroom GMP requirements within the manufacturing site • Liaises with suppliers on their bioburden controls. • Acts as the lead for customer issues on bioburden. • Acts as chief auditee on all external audits in relation to EM and site contamination control strategy. • Contributes to the GMP training program and delivers training as appropriate for bioburden. • Ensure the quality and production documentation is suitable in design for bioburden control. • Review and sign off of annual validation report of the cleanroom. • Contributing to the design and layout of the cleanroom for bioburden control • Responsible for the setting, maintaining and implementing hygiene management systems of the cleanrooms. • Support the quality function where necessary. Interested applicants should have: • BSc Degree in Microbiology (or similar) discipline. • Several years’ experience in a microbiology applied role (preferably Medical Device/Pharmaceuticals manufacturing or similar) • Excellent accuracy and attention to detail • Excellent IT, communication and interpersonal skills to communicate well, both verbally and in writing. • Ability to work on own initiative and as part of a cross-functional team

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    Private person
    Registered on 7. Oct 2017

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    Registered on October 7, 2017


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