QC管培生 — 恒瑞-全球精英计划

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

• Participate in technology transfer from R&D to production, review technology development reports and R&D quality documents, and draft technology transfer protocols.
• Perform testing and release of raw materials, excipients, intermediates, and finished products used in drug production; responsible for maintenance and calibration of analytical instruments such as HPLC.
• Draft and implement quality standard revisions, method optimization, and validation protocols.
• Investigate laboratory abnormalities, responsible for OOS, incidents, and deviations.
• Oversee laboratory compliance management and data integrity management.
• Participate in audit projects conducted by global health authorities such as FDA and EMA.
• Engage in operational excellence initiatives to improve laboratory efficiency.

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 :