Goal of function:
Responsible for all the chemical test、packaging materials test、the preparation of reagent、standardization、issuing the C.O.A, inspecting the retention sample, as well as generating specification for new drugs and analytical method validation for new drugs, help RA to finish registration documents.
1) Main tasks:
•Confirm to the requirement of regulations and procedure of lab, take charge of physical, chemical and microbial method development, validation/verification and testing of raw materials, intermediate products and finished products, issue the COA/test report, work out the procurement program of reagent and standard. Take charge of the inspection of retained sample and issuing the certificate.
•Ensure Chemist follow the instruction of sampling, testing, recording, calculating, to carry out specific projects according the specification and test method approved and well as QMS procedures and working instructions to carry out the stability study of products, and finish his duty in time.
•Lead specific project on resources allocation, instrument/equipment/working tool planning, reagents/consumables/accessories planning, task execution and corresponding status tracking, project performance and individual personnel’s performance mmonitoring, project closing, as well as communicating with co-functional teams (CCS, solution/concentration, DA, RA, etc.)
•Lead and perform OOS, OOT and OOE investigations as well as initiate non-conformity report, change control, CAPA, execute CAPA as approved.
•Close team work with support product development as well as product sustaining groups to facilitate project progress.
•Create and/or compile high quality analytical procedure, tech package or SOP, instructions, best practice as required.
• Maintain the instrument, equipment, working tools and facility to make them in a good conditions routinely.
•Ensure the chemists, engineers working in conformance with cGMP or 5S concept, company policy, SOPs, and safety regulations.
2) Secondary tasks:
• Co-ordinate external partners to complete the testing in a timely manner from technical perspective.
•Identify and introduce new analytical technologies, new techniques/equipment and modify equipment or procedures to improve efficiency and productivity.
•Assist laboratory management, includes but not limited to metrology management, material management.
•Make the purchasing plan of reagents and consumable for laboratories and specific projects as needed.
• Inform the superior immediately when OOS test results occurs. To carry out investigation when needed.
•Use the related facilities according the security procedure, improve professional abilities and skills.
•Create specification, test methods, and perform analytical method development, validation/verification for raw materials, packaging materials, intermediates, components and finished products promptly.
3) Miscellaneous tasks:
•Guide and train other staff to improve skill
• Coach contracted admin, cleaner, supplier engineer etc. to work compliantly and correctly.
• Actively identify areas for improvement in laboratory processes and implement new measure to improve efficiency.Other activities as required