Executive, Quality Control (Pharmaceutical Microbiologist)Assist the Assistant Manager, Quality Control to manage and execute laboratory operations for pharmaceutical products in the Quality Control Laboratory.
Monitor and ensure that all sampling and testing in the Microbiology Laboratory is carried out according to written procedures.
Monitor and ensure that all environmental and utilities monitoring activities are carried out on a timely basis according to written procedures.
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 the Production Area.
Responsible for monitoring and preparing the microbiological trend analysis reports on environmental monitoring in the 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 REQUIREMENT
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.#J-18808-Ljbffr