QC Micro Analyst - Athlone
PE Global are currently recruiting for a QC Microbiology Analyst for a client site in Athlone: The QC Microbiology Analyst will follow written procedures and protocols, as trained, to perform environmental monitoring, water testing, microbial testing of raw materials and in process samples. The QC Microbiology Analyst will be responsible for the execution of validation/qualification protocols. The QC Microbiology Analyst is required to work in a GMP environment meeting all expectations associated with the support of the sterile fill finish. Principal Responsibilities Environmental monitoring, water testing and all associated microbial testing to support Biologics start up and Drug Product as follows; Endotoxin testing, Bioburden testing, TOC/Conductivity testing, growth promotions, bacterial identification and Biological Indicator testing. Execution of tasks as part of Biologics start up for QC to include: Execution of URS in support purchase and qualification of QC lab equipment. Drafting risk assessment to support sampling strategy of clean utilities and cleanrooms. Drafting of test method qualification protocols. Execution of testing to support biologics start up. Perform practical work accurately and precisely. Accurate and timely recording of all information pertinent to the task being performed in the relevant Laboratory Worksheets / Notebooks and LIMS. To review and check own work results for accuracy and presentation. Participate and compile Laboratory investigations using Root Cause Analysis tools. Write and revise Procedures, deviations, CAPA, Change Controls and technical investigations and reports as assigned. Participate in Quality Risk assessments as required. Execution of validation protocols for process validation and method validation. Review of laboratory data and documentation as assigned. Ensuring training is current for all job function performed and attend all company training as required. Train and mentor other analysts/personnel as required. Daily up-keep and maintenance of Laboratory Equipment. Organize/plan/Schedule daily work schedules for assigned work /Equipment calibration or as part of a specific project using lean lab concepts. Responsibility for ordering of Laboratory Consumables and maintain sufficient stock levels. To maintain a high standard of GMP/GLP in the Laboratory. To maintain a high standard of housekeeping and Safety within the Laboratory. To adhere to all Safety / Dress Code procedures. Perform and assist in additional duties. To report to and be directed by the Laboratory Management. Qualifications Minimum of 5 years of experience in cGMP Quality environment. Experience in testing of sterile drug product and aseptic filling process of pharmaceutical /biopharmaceutical products. Experience in Method Validation. Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing. Experience in Quality Risk Management. Education Degree in Microbiology or related science. Interested Candidates should send their CV to Audrey.email@example.com or call 0214297900. This job originally appeared on RecruitIreland.com.
385 days ago