QA管培生 恒瑞-全球精英计划

Job Description

主要职责：

1.参与药品全生命周期质量管理体系的维护与优化。

2.参与FDA / EMA等全球药监机构审计项目。

3.参与质量事件管理，包括偏差调查、变更控制及CAPA有效性评估。

4.处理药品放行检测与稳定性研究的整体质量合规工作。

5.监督QC实验室数据完整性体系运行，确保分析活动符合全球药典要求。

6.参与分析方法转移和验证的合规性审核。

7.协同生产、研发、采购等部门推动质量标准落地执行。

任职资格：

教育背景 ：药学相关专业，硕士及以上学历、博士优先

相关经验 ：熟悉 FDA / EMA / WHO / ICH / NMPA 法律规范

语言要求 ：英语听说读写流利

其他技能 ：熟练操作办公软件

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 maintaining and optimizing the quality management system covering the entire drug lifecycle.
• Participate in audit projects conducted by global health authorities such as FDA and EMA.
• Engage in quality incident management, including deviation investigations, change control, and CAPA effectiveness evaluation.
• Manage overall quality compliance for product release testing and stability studies.
• Monitor QC laboratory data integrity systems to ensure analytical activities comply with global pharmacopeia requirements.
• Review compliance of analytical method transfer and validation.
• Collaborate with production, R&D, procurement, and other departments to ensure effective implementation of quality standards.

Qualifications

Education :

Master’s degree or above in Pharmacy or related fields; PhD preferred.

Experience :

Familiar with regulatory frameworks of FDA / EMA / WHO / ICH / NMPA.

Language :

Fluent in English (listening, speaking, reading, writing).

Other Skills :

Proficient in using office software.

Additional Competencies :