Sampling of all types of water from all required sampling points of water systems according to approved procedures.
Knowledge of microbiological analysis such as Total Viable Aerobic Count, Test for Specified Microorganism and Bacterial Endotoxin Test
Co-ordination and execution of environmental monitoring in the Production Drug Product and Production Drug Substance clean room areas, Quality Control Microbiology Laboratory and Inoculum Laboratory according to the schedule and approved procedures. Ensure the results are within the acceptance limit and recorded accordingly.
Issuance and review or approve the test report for all analysis on water system samples and other plant utilities, analyse the results and prepare trending for the results obtained.
Issuance and review or approve the test report for environmental monitoring activities in clean room areas, analyse the results and prepare trending for the results obtained.
Manage and update on the documentation for Quality Control Microbiology department.
Prepare and review for Standard Operating Procedure (SOP), Equipment Operating Procedure (EOP) and protocol according to current requirement and guidelines. Ensure on the implementation of the procedures.
Prepare and review for Standard Testing Procedures (STP) and Specifications for Finished Product (FP), Raw Material (RM), Packaging Material (PM), In-Process (IP) and stability study according to current requirement and guidelines. Ensure on the implementation of the procedures.
Ensure all the microbiological isolates is been identified using the biochemical test or rapid biochemical test system.
Perform investigation for laboratory Out Of Specification (OOS), non-conformance and deviation. Ensure on the implementation of CAPA.
Initiate and review of Change Management relate to Quality Control Microbiology department.
Coordinate with other departments to support in the validation or studies involving microbiological activities and compilation of the reports.
Co-ordinate for Gowning Qualification.
Involve in the Media Fill for Drug Product and ensure on the execution according to microbiological parameter requirement.
Perform risk assessments based on the requirements.
Perform self-inspections and ensure on the implementation of the corrective action and improvement plans.
Conduct training on the procedures related to general microbiological procedures, equipment, sampling or analysis and maintain the employee personnel record according to Good Documentation Practice (GDP).
Maintain the equipment in Quality Control Microbiology Laboratory and ensure the calibration or verification or qualification is performed accordingly.
Ensure all the inventory stock of consumable, disinfectant, reagents and media for sampling and analysis based on the requirement.
Review record for all equipment, reagent, media, glass wares and consumables used in the Quality Control Microbiology Laboratory.
Ensure the testing area in Quality Control Microbiology Laboratory is monitored for Temperature, Relative Humidity (RH) and Differential Pressure and all the parameter are within the limit.
Maintain the cleanliness of Quality Control Microbiology Laboratory according to Good Microbiology Practice; ensure the cleaning and disinfection activities are performed according to the schedule.
Ensure all glass ware used for any related activities are sterilized or depyrogenated using the qualified and calibrated equipment according to the approved procedures.
Support and involve in all cGMP activities organized by Quality Assurance which relate to Quality Control Microbiology department.
Ensure all the related activities perform in Quality Control Microbiology Laboratory strictly adhere to laboratory policy, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and laboratory safety guidelines.
Perform any other duties assigned by the immediate superior or HOD.
Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Master's Degree, Biology, Science & Technology, BioTechnology or equivalent.
Minimum 5 year(s) of working experience in the related field is required for this position.
Applicants must be willing to work in Nusajaya
Senior Associates specializing in Quality Control Microbiology