QC Micro Analyst / Specialist

CPL

Westmeath

QC Micro Analyst performs environmental monitoring, water testing, microbial testing of raw materials and in process samples. The QC Micro 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 sterile manufacturing. Overall Purpose: QC Micro Analyst performs environmental monitoring, water testing, microbial testing of raw materials and in process samples. The QC Micro 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 sterile manufacturing. Essential Duties, Functions and Responsibilities: Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site. Prioritises safety and is diligent in the use of all appropriate safety tools, PPE and permits when sampling or when testing in the laboratory. Maintains a high standard of housekeeping within the Laboratory. Performs environmental monitoring, water testing and associated microbial testing including. endotoxin, bioburden testing, TOC/conductivity testing, growth promotions, bacterial identification and biological indicator testing. Actively participates and can lead laboratory investigations using structured problem solving processes. Develops lab procedures and supports site procedure development as required. Executes validation protocols for process validation and method validation. Reviews laboratory data and documentation as assigned. Daily up-keep and maintenance of Laboratory Equipment. Develops and leads GMP sterility assurance training and micro awareness training to site personnel. Participates in bi-annual media fill studies to maintain line qualification status. Is diligent in the completion and review of batch and testing documentation required to meet cGMP requirements. Accuracy and timely recording of all GMP information is particularly importance in a GMP laboratory. Is always prepared to escalate any safety, quality or performance risk observed. Skills/Knowledge Required: Experience in microbiological testing of sterile drug product and of associated environmental and utilities. Experience in Method Validation. Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting commercial manufacturing. Experience in Quality Risk Management. Education Required : Degree in Microbiology. Experience Required: Minimum of 5 years of experience in cGMP Quality Control Micro Laboratory environment. Applicants should email their cv to peter.godwin@cpl.ie or call me on 01-9476227 for a confidential conversation. This job originally appeared on RecruitIreland.com.

2289 days ago