QC Micro Analyst - Carlow

Pe Global

Carlow

PE Global is currently recruiting for an QC Microbiology Analyst for a Client site in Carlow – 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 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 by leading 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. Proficient 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. audrey.brennan@peglobal.net or 00353 21 4297900. This job originally appeared on RecruitIreland.com.

2229 days ago