QC Associate Director
Brief Job Description 工作描述简述
- As technical consultant in maintain / improve GMP compliance in daily Analytical Lab operation.
维护/改进分析实验室日常运作中的GMP符合性
- Be responsible for team and personnel capability development
发展团队及人员专业技术能力
- Lead the initiatives for quality control procedure or management continuous improvement
组织和领导质量控制流程和管理的持续改进项目
- Contribute to the QA function in developing / improving quality management system
协助整个质量部改进质量管理体系
Typical Accountabilities
主要职责
Management of Analytical Lab affairs
分析实验室日常事务管理
- As technical consultant in maintain / improve GMP compliance in daily Analytical Lab operation.
作为技术顾问以维护和改进分析实验室日常运作中的GMP符合性
- Has a direct involvement in regulatory inspections
直接参与内外部法规审计
- As technical consultant in analytical technology transfer
技术支持 QC实验方法的转移
- Provides analytical expert knowledge and support to the complex troubleshooting issues, novel situations and oversees the delivery of training and coaching
提供化学分析专业知识和建议，支持复杂问题的解决并确保技术培训的实施
- Technical problem solving
技术问题的解决
Continuous Quality Improvement
持续质量改善
- As technical consultant in maintain / Improve analytical lab procedure, secure
operation GMP compliance
维护/改进分析实验室流程，确保高度的 GMP符合性
- Lead the initiatives for quality control procedure or management continuous
improvement
组织和领导质量控制流程和管理的持续改进项目
SHE 安全环境健康 - Identify and understand the SHE risk factors within the department.
识别和了解本部门的安全危险因素
- Develop and carry out plans to address the key SHE issues in the associated areas and ensure the follow up actions are carried out.
制定和执行 SHE方案以强调在相应区域的关键 SHE事件并确保跟进措施的落实执行。
Qualifications资质
Education, Experience and Training
教育、工作经验和培训
• Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry.
大学本科以上学历，药学、化学分析或相关专业毕业
• 5+ years prior experience in GXP environment of pharmaceutical industry
制药行业 5年以上工作经历
• 5+ years prior experience in quality control - analytical
具有至少 5年从事药品分析检验工作
• Knowledge and a comprehensive understanding of the principles and concepts of compliance management and Good Manufacturing
Practice/Good Laboratory Practice
对法规符合性管理的要求和概念、GMP/GLP具有丰富知识和深入的理解
• Experience of analytical method transfer or validation.
分析方法转移或验证经验
• Overall quality management system and GMP knowledge
具有全面地质量管理体系和 GMP知识
• Capability of providing direction to the analytical lab including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology.
能够为分析实验室在仪器管理、方法学问题、非常规的分析测试以及新技术的评估和应用方面提供指导
• Good collaboration, team coaching and people development capability
良好的合作、团队建设和人员发展能力
• Good command of English
良好的英文能力
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
