Microbiology Manager

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My client, a start-up biologics manufacturing facility in Waterford, are looking for a Microbiology Manager to join their team.The CompanyGlobal biopharmaceutical company focused on improving patients' lives through commercialising quality, innovative medicines prescribed by primary care physicians, specialists and those who treat patients with rare diseases.The company markets a portfolio of medicines through its orphan, primary care and rheumatology business units. The company's global headquarters are in Dublin. The company also has offices in the US and Europe. This role will be based in their start-up manufacturing facility in Waterford.The PositionThe purpose of the Microbiology Manager is to be the subject matter expert in our Microbiology function and to manage and co-ordinate all activities in the Microbiology Laboratory including scheduling and people managementResponsibilities:Be the Site expert on microbiology; providing company-wide guidance and expertiseIntroduce microbiological testing and provide support to the site including scheduling of all activities within Microbiology laboratoryCo-coordinating and managing Microbiology Analysts and supporting them in their roleManaging the Microbiology laboratory schedule to support operational activitiesPerforming support equipment URS, equipment implementation and laboratory set upEnsuring that the existing laboratory tools are used to generate and maintain performance related metricsExecution of routine utilities QC-Micro testing and environmental monitoring compliance with cGMP and Standard Operating ProceduresOverseeing the timely close out of deviations and/or investigationsEnsuring the timely completion of data reviewing as requiredIdentifying training requirements of Microbiology Analysts within laboratory and organize training as requiredDrafting procedures and company documentation as requiredEnsuring that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.Ensuring microbiology laboratory personnel adhere to all good housekeeping practicesIdentifying and making recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.Representing the Microbiology laboratory at various meetingsJob Type: Permanent/Full timeQualifications and Skills Required:Qualified to a minimum of degree level in science discipline with a post-graduate qualification advantageousAt least 5 years' experience in microbiology pharmaceutical laboratoryPrevious experience in injection facility/sterile fills desirableGood working knowledge of Regulatory Guidance for manufacture of sterile fill finish productsSupervisory management experience advantageousPrevious cross-functional project experienceGLP expertKnowledge of GMP guidesFor immediate consideration please apply with an up to date CV. Not sure yet? Would like more info? Please get in touch with me to discuss further. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales