Operate QC analysis in compliance with analytical methods, Assuring quality, Good Documentation Practices, cGMP, safety health and environmental standards are met.
Constitutes standard operating procedures, analytical methods and perform the equipment qualification.
Analysis of raw materials, semi-finished, finished products, validation sample and project sample according to the analytical methods and pharmacopoeia requirements.
Assures that analysis is carried out on time and are in compliance with the Specifications. Participate in the OOS investigations.
Implements the maintenance/validation/verification of laboratory equipment in compliance with the established schedules and maintain accurate records and documentation.
Maintain the reference standards as well as the relevant documentation and record. Maintain the reagents and their records.
Support the QC Supervisor with writing draft procedures, draft qualification protocols of the analytical instruments and the analytical methods. Perform the qualification work.
Implement stability study according SOP and finish stability report on time
To be the backup of the other analysts in case of absent.
Other works assigned by the leader.
Better to have : 优先考虑项
Technical 技能: Can operate and maintains the analytical instrumental such as HPLC, GC, UV, IR, Dissolution tester. 能操作及维护各种分析仪器，如高效液相，气相，紫外，红外，溶出仪等。
Language语言: Communicate fluently in English.能用英语交流。
IT Skill电脑技能: Senior in office software . 熟练使用办公软件。
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