Conducts testing in compliance with all regulatory and technical requirements, and contributes to maintain the QC activities (documentation, methods, competencies etc.) at the required operating level.
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.
Education / Experience教育及经验要求：
Must to have : 最低要求
Education教育: Bachelor degree/大学本科
Professional /Major专业：Pharmacy related major/药学相关专业
Experience 经验: At least 1 year chemical analysis experience in QC or 2 year experience in Pharmaceutical.
Better to have : 优先考虑项
Professional /Major专业：Pharmacy analyst药物分析专业
Experience 经验: More than two years working experience in QC. Be familiar with chemical analysis and have experience in analytical method and instrumental validation.两年以上QC工作经验，熟悉QC 理化分析, 有分析方法和仪器验证工作经验。
Technical skills & Competencies / Language 技能及其他能力要求
Must to have . 最低要求
Technical 技能: Can operate the analytical instrument in QC such as HPLC, GC, UV, IR, Dissolution tester. 能操作实验室基本分析仪器，如高效液相，气相，紫外，红外，溶出仪等。
Language语言: Basic English reading and writing. 英语基本读写能力
IT Skill电脑技能: Basic office tools基本办公软件操作
Other Ability其他能力: Co-operate with the team团队合作
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。
Future challenges 未来的挑战：Strive for the annual target and become an expert in the responsible field/达成年度目标并成为负责领域的专家
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