Lab Chemist (Analytical Chemist)
Detail posisi
Kewajiban
• 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
Kualifikasi
• Flexibility in Working Hour (Able to work as shift - Day & Night (50/50) and Overtime)
• Normal Working Hour: Mon-Fri 8:00-5:00