Microbiology Analyst - Carlow
PE Global is currently recruiting for aMicrobiology Analystfor a Client site in Carlow - Our client in Carlpw are currently looking for an effective Quality Control Microbiology Technician to join their expanding group of dedicated highly experienced people. The ideal candidate will demonstrate knowledge of microbiology test methods and techniques, understanding of aseptic technique and aspeptic processing. Key aspects of the role include : Responsibility for quality control of the environmental, utility monitoring programs to ensure compliance with internal and worldwide regulatory standards. Carrying out routine testing and test method validation/qualification of drug product for microbiological/chemical attributes as required. Participate in all Quality related functions that directly support the Integrated Process team (IPT) and the site value stream map. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to customers. The Quality Control Microbiology Technician role will report directly to the Microbiology Laboratory Manager. Requirements: The ideal candidate will have 2 plus years’ experience in a laboratory role. He/she will also have excellent communication, presentation and interpersonal skills to interface effectively with all levels of collegues and with external customers. Ability to problem solve while working to strict deadlines in a regulated environment with minimal supervison is also essential. The role includes but not limited to: Perform in process and release testing of drug product including Sterility, Bacterial Endotoxinand Bioburden in accordance with the validated methods, ensuring compliance to regulatory filings. Performing method qualifications/validations of new products in line with site Plan of Record. Perform environmental monitoring, water monitoring, lab support testing including identification of Isolates, Bioburden and Endotoxin testing in accordance with GLP, GMP and regulatory requirements. Support process simulations by performing inspection, reconciliation and growth promotion testing as required. Support/perform environmental monitoring of clean rooms and controlled environments. Support and comply with safety and compliance initiatives on site. Support/perform media growth promotion and maintenance of Stock Cultures. Operation of laboratory equipment and stock levels and perform general housekeeping activities. Participate in training and personal development opportunities identified by the Microbiology Laboratory Manager. Participate in effective writing/revising/ rolling out of accurate operational procedures, training materials and procedures for various Quality systems; ensure all work is subsequently carried out in line with same. Actively participate and promote continuous improvement in the Microbiology Laboratory byleading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system. Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Qualifications, Skills & Experience Required - Minimum of 2 years experience in a Pharmaceutical Microbiology Industry. Bachelor of Science Degree or higher in Microbiology or bioscience. Demonstrate knowledge in microbiology related test methods i.e Bioburden, Endotoxin and Sterility testing. Understanding of aseptic processing requirements and knowledge of aseptic technique. Knowledge regulatory / code requirements to Irish, European and international codes, standards and practices. Report, standards, policy writing skills required. Proficienct in Microsoft Excel, Word, PowerPoint. Effective time management and multi tasking skills. Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail. Demonstrate ability to clarify, communicate and solve problems. Interested candidates should submit an updated CV, marked for the attention of Audrey firstname.lastname@example.org or 00353 21 4297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.
9 days ago