We would like to invite applications for the role of Site Microbiologist at our Waterford site. This is a Permanent Position.
The Site Microbiologist is responsible for the Management of the Microbiology Lab and defines the microbiology strategy for the site in order to meet our company's Operational and Quality objectives.
The successful person will be managing the full micro team for the site along with reviewing departmental performance and acting as the site main contact for all micro related queries.
Main Responsibilities:
· Responsible for all micro queries and investigations around the site
· Liaising with senior management on all queries relating to the micro team
· Proactively plans for, develops and implement new projects and systems for the micro team on an ongoing basis
· Being a subject matter expert on all matters relating to micro
· Supports and drives the Contamination Control Strategy for the site in accordance with Annex 1 requirements
· Develop and train the micro analysts on the team to the best standards
· Deliver Customer Service (both internal and external) in accordance with Quality standards, 'Best Practices' and Cost Control.
· Ensure that operational schedules are met with all batches being ready as needed
· Ensure GMP compliant, cost effective systems are developed in place and operational in order to ensure all work carried out by Microbiology personnel is in compliance with required standards conforming to our company's, cGMP, and Health and Safety, Best Practice and Environmental requirements.
· Ensure the team are fully ready for all audits and inspections as required
Who we are looking for
· Third Level qualified in Microbiology (essential)
· Extensive management experience in a high throughput Laboratory within the Pharma industry?
· Excellent Knowledge of Regulatory USP/Ph.Eur/JP harmonised microbiological methods, method verification/development ensuring the site is in compliance with all micro regulations
· Comprehensive Knowledge of Microbiology and Microbiological Techniques in the Pharma Industry
· Knowledge of Steam Sterilisation and microbiological media.
· Knowledge of environmental control, routine monitoring and method validation.
· Understanding of microorganisms and bioburden/contamination control and the risk associated with non-sterile inhalation products.
· Knowledge of PW systems and microbial control
· Knowledge of microbial identification methods
· Good understanding of Contamination Control Strategy and Annex 1 requirements