Job Description
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below; Micro Analyst The Microbiology Analyst is responsible for the carrying out routine microbiology laboratory activities including environmental monitoring of cleanrooms, microbial analysis of site utilities and testing of raw material, commercial, clinical and development batches. Further, the position holder will manage the microbial analysis of Allergan products included in the Global Stability program. Microbial monitoring and testing are performed in line with regulatory requirements. Responsibilities Perform key tasks for release and stability testing such as: Environmental Monitoring water sampling bioburden in-process testing endotoxin growth promotion Sterility testing APET Antibiotic Assay Report writing Draft and review documentation -SOPs, protocols, training modules, investigations, reports, CAPAs and deviations Trending of results and preform investigations into adverse or out of limit results Validation of equipment and microbiology test methods Education & Key Requirements 3rd Level Qualification in Microbiology or equivalent scientific degree 12 months working in a manufacturing environment. Preferably Aseptic processing. Working knowledge of both Pharmaceutical Industry and sterile processing. Strong background in Aseptic's and/or Microbiology Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of sterile products. Performs routine and non-routine Microbiological testing activities as required. Ensures that all testing is completed, reviewed and approved within agreed turnaround times. Ensures activities are carried out in compliance with product license commitments, cGMP, company quality standards and legislative regarding health, safety and environment. To start the process click the Continue to Application or Login/Register to apply button below.