QC Executive

Job Responsibilities :

• Ensure that raw materials and finished products fall within the microbial assay and microbial limit permitted in the specification so as they meet the drug Control Authority requirements and the client's acceptance by performing microbiologist test, recording and reporting the results, in a timely manner.
• Coordinate & lead the team on sampling for environmental monitoring & deionized water monitoring, and testing of in-coming raw material, packaging material, bulk / finished product and stability study been conducted are follow as per approved procedure and GMP requirements.
• Ensure effective sterilization of glassware and culture media prepared in-house through validation with biological indicators.
• Monitor microbial levels in purified water, air in the production environment and microbial laboratory, contact surfaces of equipment and building structure.
• Evaluate chemical quality of water in accordance to stipulated test and interval.
• To ensure any OOS or OOT or deviation related to microbiology section been conducted as per specified timeline as per approved procedure
• Minimize contamination of specimens by speedily identifying pathogens or any unwanted organisms in the test specimens, preparing checklists for sterilizing and cleaning of apparatus, and constantly improving on methods used to detect causes of contamination.
• Assist in monitoring the laboratory and its activities safe operation of equipment and to be in strict compliance with GLP by ensuring proper maintenance of laboratory equipment in good working order, timely replenishment of primary reference standard, standardization of secondary reference standard and standardization of volumetric solution, informing laboratory personnel of correct procedure in handling hazardous chemical, providing the necessary safety tools and gadgets and proper supervision of experiments.
• Assist in continuous improvements of QC activities through the regular conduct, reviewing and reporting of quality test procedures so as to minimise quality deviations.
• Ensure that all relevant standard operating procedures, test protocols, validation documents are revised and updated in accordance to stipulated interval
• Lead and conduct the Analytical method validation for micro bioassay and other microbiology testing related to prepare the protocol, execution, and report according to latest monograph (BP / USP / EP).
• Understand how to evaluate and review the monograph method which then to be translated into in-house test protocol for microbiology routine testing.
• Involve and support in correspond any regulatory enquiry with regards to microbiology testing
• Conduct in-house training to the lab technician microbiology on all aspects of microbiological responsibility and responsible to all microbiology laboratory equipment
• To participate actively in self-inspection programs organized by QA department
• In charge of routine purchase for micro lab chemicals, glassware, and consumable.
• Responsible to laboratory equipment & apparatus that have been assigned for equipment ownership
• In the absence of QC Manager & Assistant QC Manager, to carry out all managerial works related to registration documentation and full observation on the microbiology section operation & management.
• Any other duties whenever assigned

Job Requirement