Site Microbiologist - County Waterford

ICDS RECRUITMENT

Waterford

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.

447 days ago