Quality Specialist - Microbiology
About Your New Employer A world leading biopharmaceutical company with sites all across Ireland. This site the filling site for the liquid form of our client’s immuno-oncology treatment for the global market and is a state-of-the-art vaccines and biologics facility. About Your New Job This role is responsible for all aspects of method and equipment validation in the microbiology department assisting in the effective and efficient running of the method and equipment validation programs. In addition, providing on-going technical support to the site in the area of microbiology and contamination control. Technical support and provision of technical leadership in microbiology to other area. personnel. Development of Microbiological methods, Method Validation and Method Qualification, mainly. bioburden, endotoxin and Sterility test methods. Analytical Method Transfer and Qualification. Approval of procedures, protocols, reports and other GMP documents as required. Performance, design and direction of bench experiments for validation purposes. Troubleshooting of issues which arise during the execution of validation studies and routine. tests. Microbiology Support to Site Investigations. Driving Continuous Improvement initiatives, including lean lab initiatives, method. optimization/redevelopment. Participation in Specifications Development as required. Laboratory Equipment Qualification / Risk Reduction. Procedural updates. General Analytical Support to Quality Control Laboratories. Supporting the environmental control program by trend analysis and implementation of. appropriate corrective and preventative measures. Troubleshooting of suspected Microbiological Contamination events. Acts as a resource to colleagues with less experience in Microbiology. Leads analytical microbiology project improvement teams. Coaches and guides colleagues within the site and also in the network on analytical microbiology. Understands and applies regulatory / compliance and compendial requirements to their role. together with remaining current on upcoming regulatory and compliance changes. Assessing compendial and regulatory updates in regards to the area of Microbiology and. Laboratories. Interprets customer needs, assesses requirements and identifies solutions to non-standard. requests. Makes decisions within guidelines and policies which impact microbiology projects. Liaises with the global Microbiology Network to ensure alignment on actions related to the. relevant Quality bulletin/QMS and regulatory changes. Works with sister and other sites to aid them in Microbiology related topics, as required. Ensure highest safety standards. May be required to perform other duties as assigned. What Skills You Need Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline. Demonstrated change management skills (CEM) with continuous improvement. Demonstrated knowledge in microbiology related test methods i.e. Bioburden, Endotoxin and Sterility testing. The ideal candidate will have at least 7 years’ experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 3 years’ experience in a Microbiology function. What’s on Offer in this Temp / Contract role. Hourly rate up to €40/hr. 11 month contract. High possibility of contract extension or conversion to a permanent role with the client. What’s Next If you’re interested in hearing more, apply now by clicking the “Apply Now” button or call me, Niall Crosbie on + 353 896046664. Why Apply Through Sigmar? Sigmar's awesome Payment terms – Temps are paid every Thursday / we pay all our Contractor invoices within 5 days! We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV. We’ll provide you with an overview of the jobs market within your industry and help you tailor your jobs search. Gain access to exclusive roles that are not advertised elsewhere.
12 days ago