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
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:
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