主要职责:
1.参与药品从研发到生产的技术转移,审核技术开发报告、研发质量文件,起草技术转移方案
2.负责药品生产所用原辅料、中间体、成品的检测及放行,HPLC等分析仪器维保与校验
3.承担药品质量标准修订、方法优化,验证方案的起草、实施
4.跟进实验室异常情况,负责OOS、异常、偏差等的调查
5.监督实验室合规管理、数据完整性管理
6.参与FDA/EMA等全球药监机构审计项目
7.参与卓越运营管理,提升实验室运营效率
任职资格:
教育背景 :药物分析相关专业,硕士及以上、博士优先
相关经验 :熟悉USP美国药典
语言要求 :英语听说读写流利
其他技能 :熟练操作各种分析系统软件
能力要求:
1.对药品生产领域有浓厚的兴趣,并愿意在该领域长期发展
2.逻辑清晰,有科学严谨的工作思路
3.主动性强,学习能力强,富有热情
位置:连云港、成都、山东、福建、上海、苏州、广东
Main Responsibilities
Qualifications
Education:
Master’s degree or above in Pharmaceutical Analysis or related fields; PhD preferred.
Experience:
Familiar with the United States Pharmacopeia (USP).
Language:
Fluent in English (listening, speaking, reading, writing).
Other Skills:
Proficient in using various analytical software systems.
Additional Competencies:
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