QC物料检测研究员(J24185)

1、 计划和执行原辅料和包材的分析方法开发、验证和转移。

Plan and execute development, validation, and transfer of analytical methods for APIs, excipients, and packaging materials.

2、 在GMP体系下，进行样品检测分析，包括但不限于原料药、辅料和包材。

Perform sample testing and analysis under GMP system, including but not limited to APIs, excipients, and packaging materials.

3、 撰写正式的分析方法、方法验证报告、分析证书(CoA)和/或与分析研究和开发工作相关的摘要/报告。

Prepare formal analytical methods, method validation reports, Certificates of Analysis (CoA), and/or summaries/reports related to analytical R&D work.

4、 按照5S 要求，进行实验室整理。

Maintain laboratory organization in accordance with 5S requirements.

5、 与相关部门沟通协调， 确保物料及时放行。

Communicate and coordinate with relevant departments to ensure timely release of raw materials.

1、 药学或化学等相关专业本科及以上，具有2年以上的原辅料分析测试经验。有扎实的实验操作技能，熟练操作分析实验室理化实验，如手动滴定，红外，UV等，熟练操作HPLC和GC。

Bachelor’s degree or higher in Pharmacy, Chemistry, or a related field, with at least 2 years of experience in APIs and excipient analysis/testing. Solid laboratory skills with proficiency in physicochemical tests (e.g., manual titration, IR, UV) and routine operation of HPLC and GC.

2、 具有良好的GMP意识，及时准确完成相应检测及记录书写。

Strong GMP awareness; able to complete required testing and documentation accurately and on time.

3、 做事严谨，有较强GMP意识和责任心，具有团队协作能力。

Meticulous and responsible with strong GMP mindset and teamwork skills.

4、熟练的英文阅读和书写能力，能查询英文期刊和药典等；良好英文听说能力，能简单沟通。

Proficient in English reading and writing for consulting journals and pharmacopeias; good spoken English for basic communication.