Job Description
Duties & Responsibilities Provide Microbiological support to the site Develop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations. Testing of In-process, Drug Substance and Drug Product Batches manufactured. Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes. Lead all environmental investigations, root cause analysis, and report close out. Lead monthly environmental review meetings and present all relevant trends to a cross departmental team. Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees. Validation of microbiological methods e.g. bioburden and endotoxin. Support autoclave validation programme. Stability testing of Drug Substance and Drug Product Batches Participate in Quality and Safety regulatory audits. Support raw material testing when required for GMP manufacture Input into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation. Troubleshooting equipment and techniques within the Analytical team. Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATION Qualifications, Experience, Skills, Knowledge and Attributes Third level degree in a life Science discipline 2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects. Highly organised and structured approach to task completion. Strong time management awareness and the ability to drive projects forward. Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Full time Legal statement as below This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula. Visa status re must be eligible to work and live in Ireland as below Colleague must be legally eligible to live and work in Ireland. Summary of our Benefits In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.