Job Description

Summary

To carry out routine microbiology laboratory operations, this includes full range of cleanroom environmental monitoring activities, and product related testing activities; Expected to be competent in own area of scope (i.e. Environmental Monitoring or Product Testing), include rendering support and guidance to other team members in the organisation on non-routine microbiological testing for validation and engineering studies, and resolution of causes to operational issues; To assist with reviewing of microbiological test data, laboratory investigations in the absence of the lab manager or person in charge; Ensure testing elements (e.g. methods, equipment, and lab practices) are in compliance with various regulatory requirements;

Responsibility

Perform routine/non-routine microbiological testing on raw materials, in-process samples, finished products (pre and/or post sterilize), as well as environmental monitoring according to established procedures. Perform quality checks for media used in testing and maintain masters / cultures used for testing. Implementing and maintaining the lab environmental conditions. Review product/environment microbial trends, highlight emerging trends, uncommon bacteria occurrence. Coordinate 3rd party lab microbiological testing activities (e.g. bacterial identification, endotoxins test). Qualify and maintain respective laboratory equipment to ensure they are fit for its intended usage, with proper calibration and maintenance program established. Ensure continuous flow of all necessary resources (e.g. supplies, trained analysts, equipment) to enable smooth activities in the laboratory. Ensure accuracy, integrity, traceability and reliability of test report generated, as well as sample information submitted. Ensure proper filling and retention of test reports. Maintain and prepare work instructions to ensure compliance with reference standards. Lead laboratory equipment and test method validation / revalidation activities through establishing protocols, execution, and report documentation. Provide support for personnel qualification and re-qualification, and cleanroom re-qualification. Perform and/or support investigation and documentation of non-compliance or out-of-spec situations. Lead and/or review internal laboratory investigations. Responsible for respective training activities for newcomers and qualify them on microbiological test methods. Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment. Monitor documentation and implementation of ISO/IEC 17025.

Requirement

Bachelor/Diploma in Science discipline (e.g. Pharmaceuticals Science, Microbiology, Biological Science) At least 2-3 years of relevant experience in a laboratory environment Cleanroom/environmental control experience is essential Good knowledge of microbiological test methods (e.g. Bioburden, endotoxins, sterility tests) Knowledge of aseptic techniques, and GLP Excellent Interpersonal and communication skill High level of integrity, a self-starter and ability to work independently Able to work under stress and deliver work schedules Knowledgeable of applicable standards such as ISO 13485, ISO/IEC 17025, preferably to have knowledge on ISO14644, ISO17141, ISO11737 and ANSI/AAMI-ST72 Experience in Quality Assurance or medical device/manufacturing environment would be an advantage Relevant Microsoft Office Applications Preferable to have experience in QMS audit/internal audit/supplier audit in the context of ISO13485/9001 or the equivalence * Good analytical and problem solving skills (FMEAs, 5-whys, 8D etc...)