工作职责




* Follow SOP to perform release testing on raw material, finished product
* Plan, organize daily testing activities, ensure data accuracy and data
integrity demand
* Coordinate with lab task leader and communicate with peers to ensure
progresses, issues are shared in timely manner within lab level
* Be responsible for the testing of raw materials, finished products and
stability samples, follow release cycle time, operational procedure and data
integrity purpose
* Continuous improvement on testing efficiency, analytical knowledge and
equipment operation / maintenance skills
* Acting as owner of assigned areas, process and equipment, ensure lab
operation business continuity
* Closely coordinate with lab task leader to ensure detail work plan and
deliverables are well monitored and delivered
* Be responsible for lab consumables, such as columns, reagent, reference
standard life cycle management, ensure business continuity and GMP compliance.
* Build up data analysis and problem-solving capabilities on analytical
process and equipment, predict risk and define proper action to ensure problems
are properly identified, risk assessment and solutions are effective, and
escalated to the right person at the right time
* Prepare / design lab SOPs, instructions and study protocols
* Other tasks assigned by line manager



任职要求




* Bachelor’s degree or above in analytical chemistry or pharmacy related
majors
* 3+ years pharmaceutical lab experience
* Familiar with pharmacopeia (e.g., Ch.P, EP and USP etc.)
* Familiar with analytical equipment such as HPLC, GC, UV, Titrator...
* Familiar with regulatory requirements (e.g., cGMP / EU / FDA)
* Good self-driven, cordination, communication skills
* Logical based decision making / problem solving skills
* Good learning ability and result orientation, accuracy, ect.