Key responsibilities 重要职责 (1) Quality inspection and release. 质量验收和放行。 (2) Quality management (e.g. deviation, change control, quality incident, risk assessment etc.) for owned processes, suppliers, products. 对所负责的流程、供应商、产品涉及的偏差,变更,质量事故,风险评估的质量管理。 (3) QA BP for assigned computerized system, ensure quality compliance and support continuous optimization. 作为指定计算机化系统的QA BP,确保所负责的计算机化系统质量合规并支持持续优化。 (4) Product supplier and product first-supply and change Management 产品供货单位和品种首营及变更管理 (5) Management of Product Temperature and Humidity Excursion Assessment. 产品超温超湿评估管理。 (6) Other task assigned by line manager. 完成直线经理交办的其他任务。 Education 教育背景 · College degree or above in pharmacy, biology, chemistry, medicine or other related area. 具有药学、生物学、化学、医学或其他相关领域的大学本科及以上学历。 · Familiar with local GDP (GSP)/GMP. 熟悉当地的 GDP(GSP)/GMP。 Experience 经验 · Above 3 years quality experience in GMP or GDP (GSP) area. 在GMP或GDP(GSP)领域具有3年以上的质量经验。 · Above 1 year’s quality experience for product inspection and release. 在产品验收和放行方面具有1年以上的质量经验。 Personal skills 技能 · Good English skill at reading, writing, listening, and speaking. 良好的英语读、写、听、说能力。 · Good communication skills of both scientific and non-scientific information. 良好的科学与非科学信息的沟通能力。 · Professional knowledge in local regulations. 具备当地法规的专业知识。 · Problem solving ability and skills. 具备解决问题的能力和技能。 · Ability to face challenge and self-learning. 能够应对挑战并具备自我学习能力。