Executive, Quality Control (Pharmaceutical Microbiologist)

Executive, Quality Control (Pharmaceutical Microbiologist)

Assist the Assistant Manager, Quality Control to manage and execute laboratory operations for pharmaceutical products in Quality Control Laboratory.

• Monitor and ensure that all sampling and testing in Microbiology Laboratory is carried out according to written procedure.
• Monitor and ensure that all environmental and utilities monitoring activities are carried out on a timely basis according to written procedure.
• Ensure strict adherence to laboratory compliance with PIC/S cGMP (current Good Manufacturing Practice), ISO (9001, 13485 and 17025) and SHE (Safety, Health, & Environment) requirements.
• Responsible for continuous improvement of QC laboratory procedures and protocols to enable the delivery of good quality products on a timely basis.

JOB DESCRIPTION

• Manage and execute the environmental and utilities (water systems, pure steam, gases and compressed dry air) monitoring activities for the Microbiology Section, Quality Control Laboratory.
• Manage and execute the process of EM-LIMS software for microbiological testing of environmental and utilities monitoring; creation, review, approval and extraction of data.
• Responsible for monitoring and preparing the microbiological trend analysis reports on utilities monitoring in Production Area.
• Responsible for monitoring and preparing the microbiological trend analysis reports on environmental monitoring in Production Area.
• Coordinate sampling and testing for packaging material, raw materials, in-process (IPQC) and finished products (FPQC) to ensure the microbiological test results are released on a timely basis.
• Develop and maintain standard operating procedures, test protocols, work instructions and other documents related to Microbiology according to the guidelines.
• Coordinate and conduct method validation, verification and transfer activities for the microbiology and analytical test methods as per the agreed timeline.
• Check, review and approve microbiological testing reports conducted by Microbiology Lab personnel, when required.
• Maintain laboratory compliance and housekeeping according to PIC/S cGMP, ISO, SHE and other related requirements in the Microbiology Laboratory.
• Conduct training and assess team members’ performance in handling their routine work in compliance with PIC/S (cGMP), ISO and SHE guidelines.
• Perform Sterility Testing, Bacterial Endotoxin Testing, and Bioburden Testing according to the test methods and specifications, as and when the expertise is needed.
• Responsible for purchasing laboratory supplies (consumables, media, chemical, disposable).

JOB REQUIREMENTS

• Must possess at least a Bachelor degree in Microbiology or other life science related field.
• Minimum 4 years of working experience in a related industry.
• Knowledge of cGMP, good laboratory practice (GLP) and ISO (9001, 17025 and 13485) are required.
• Knowledge of microbiology in the pharmaceutical industry and handling laboratory instruments are essential.
• Analytical skills and must be well-versed in documentation.
• Good understanding of scientific and technical data.