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

1. Participate in maintaining and optimizing the quality management system covering the entire drug lifecycle.
2. Participate in audit projects conducted by global health authorities such as FDA and EMA.
3. Engage in quality incident management, including deviation investigations, change control, and CAPA effectiveness evaluation.
4. Manage overall quality compliance for product release testing and stability studies.
5. Monitor QC laboratory data integrity systems to ensure analytical activities comply with global pharmacopeia requirements.
6. Review compliance of analytical method transfer and validation.
7. 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:

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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