Technical Leader – Lab Operation
Goal of function:
Responsible for all the chemical test、packaging materials test、the preparation of reagent、standardization、issuing the C.O.A, inspecting theretention sample, as well as generating specification for new drugs andanalytical method validation for new drugs, help RA to finish registrationdocuments.
1) Main tasks:
• Confirm tothe requirement of regulations and procedure of lab, take charge of physical,chemical and microbial method development, validation/verification and testingof raw materials, intermediate products and finished products, issue theCOA/test report, work out the procurement program of reagent and standard. Takecharge of the inspection of retained sample and issuing the certificate.
•EnsureChemist follow the instruction of sampling, testing, recording, calculating, tocarry out specific projects according the specification and test methodapproved and well as QMS procedures and working instructions to carry out thestability study of products, and finish his duty in time.
•Lead specificproject on resources allocation, instrument/equipment/working tool planning,reagents/consumables/accessories planning, task execution and correspondingstatus tracking, project performance and individual personnel’s performancemmonitoring, project closing, as well as communicating with co-functional teams(CCS, solution/concentration, DA, RA, etc.)
•Lead andperform OOS, OOT and OOE investigations as well as initiate non-conformityreport, change control, CAPA, execute CAPA as approved.
•Close teamwork with support product development as well as product sustaining groups tofacilitate project progress.
•Create and/orcompile high quality analytical procedure, tech package or SOP, instructions,best practice as required.
•Maintain theinstrument, equipment, working tools and facility to make them in a goodconditions routinely.
• Ensure thechemists, engineers working in conformance with cGMP or 5S concept, companypolicy, SOPs, and safety regulations.
2) Secondary tasks:
•Co-ordinateexternal partners to complete the testing in a timely manner from technicalperspective.
•Identify andintroduce new analytical technologies, new techniques/equipment and modifyequipment or procedures to improve efficiency and productivity.
•Assistlaboratory management, includes but not limited to metrology management,material management.
•Make thepurchasing plan of reagents and consumable for laboratories and specificprojects as needed.
•Inform thesuperior immediately when OOS test results occurs. To carry out investigationwhen needed.
•Use therelated facilities according the security procedure, improve professionalabilities and skills.
•Createspecification, test methods, and performanalytical method development, validation/verification for raw materials,packaging materials, intermediates, components and finished products promptly.
3) Miscellaneous tasks:
•Guide andtrain other staff to improve skill
•Coachcontracted admin, cleaner, supplier engineer etc. to work compliantly andcorrectly.
•Activelyidentify areas for improvement in laboratory processes and implement newmeasure to improve efficiency.Other activities as required