Lab Chemist

Location: Nikom Amata City Rayong

Report to: Assistant Manager, Laboratory
Job Scope: Conduct specific chemical and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming raw materials to finished goods and Stability study, include environmental monitoring programs.

Job Descriptions:

• Conduct critical chemical and physical analyses such as raw materials, initial, in-process, final products, stability study and samples collected from environmental monitoring programs at Baxter manufacturing facilities, etc.

• Conduct the incoming inspection (visual, dimensional and functional), review the result and release as per timeline

• Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS system).

• Perform assays requiring precise analytical skills and understanding of chemistry principles.

• Complete all testing, including special project / protocol testing in a timely and appropriate manner.

• To review the testing result of API, in process, finished product and Stability including result of incoming inspection.

• Maintain data integrity and ensure compliance with company SOPs and USP specifications, FDA, GLP and cGMP regulations.

• Ensure that the test results generated within the Chemistry lab are precise, accurate and completed on time.

• Be responsible for writing validation/Qualification protocols, reports and relevant test methods, new equipment and SOPs.

• Ensure that the test equipment is calibrated and in good condition before use.

• Keep tidiness in laboratory and ensure that the laboratory is properly and safely equipped to the international standard.

• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.

• May perform equipment maintenance and calibrations as required.

• To review the final analysis result of raw materials, finished product, stability result and document which related within chemical Laboratory.

• Handling of Supplier Corrective Action Request (SCAR) and INTRA COMPANY CORRECTION/CORRECTIVE ACTION REPORT (ICAR) for packaging material and API.

Qualifications:

• Bachelor's degree in chemistry, or related science

• 3 years’ experiences in Quality Control, Analytical Laboratory in a pharmaceutical manufacturing environment

• Having knowledge in method validation, GMP, PIC/S, ISO 9001, ISO13485, Good Laboratory Practices, and ISO 17025 will be an advantage.

• Workable command of English and Computer literacy

• Flexibility in working hours

• Ability to handle multiple tasks concurrently, and in a timely fashion.

• Computer literate. Must be detail oriented, conscientious and have high reading comprehension skills.

• Knowledge of cGMP manufacturing, basic laboratory and pharmaceutical production equipment including but not limited to autoclaves, process tanks, incubators, analytical equipment.