Job Description

Job Description

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

1. Participate in technology transfer from R&D to production, review technology development reports and R&D quality documents, and draft technology transfer protocols.
2. 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.
3. Draft and implement quality standard revisions, method optimization, and validation protocols.
4. Investigate laboratory abnormalities, responsible for OOS, incidents, and deviations.
5. Oversee laboratory compliance management and data integrity management.
6. Participate in audit projects conducted by global health authorities such as FDA and EMA.
7. 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:

1. Strong interest in pharmaceutical production with willingness for long-term development in this field.
2. Clear logical thinking and a rigorous scientific mindset.
3. High initiative, strong learning ability, and enthusiasm.

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