QC Associate Director (Micro lab)
Provide leadership to Microbiological lab by ensuring GMP and regulatory compliance, people management skills, guiding team direction.
领导微生物实验室部门确保相关GMP 和法规符合性，团队管理指引团队战略方向
• Maintain / improve GMP compliance in daily Microbiological Lab.
维护/改进微生物实验室日常运作中的GMP符合性
• Establish, develop, and maintain a highly efficient quality control team to contribute and add value to the AstraZeneca China Quality Function, and entire supply chain.
建立发展高效的质量控制团队，贡献于质量职能部门以及整个供应链
• Build and develop team and personnel capability.
建立和发展团队及人员能力
• 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
- Leading the department ensure all the activities comply with GMP requirement.
确保无锡工厂的分析检验活动符合GMP 的要求
- Manage and develop capital and expense budgets for the analytical laboratories and drive cost/waste reductions where appropriate. 制定和管理实验室的资产固定资产投资和费用计划，推进成本/浪费降低。
- Proactively looks for opportunities to identify change and make efficiency savings, influence decisions, and deliver the results whilst ensuring an appropriate level of compliance.
主动寻找机会来识别变化并提升效率，参与决策以达到成果，同时确保合规性。
- Leads and directs the introduction of new technology/systems/Digital solution into the Lab, oversees and manages initiatives to ensure that the Lab remains contemporary and competitive.
领导并指导将新技术/系统引入实验室，监督和管理项目以确保实验室的现代化和竞争力。
- Influencing and contributing the global Microbiological standard and strategy.
贡献和影响全球微生物的标准和相关的策略的实施
- Maintains a watching brief on industry standards and innovations, directs and oversees the evaluation and development of implementation proposals where
appropriate.
保持对行业标准和创新的关注，在适当的情况下，对实施建议的评估和制定进行指导和监督。
- Provides supervision and support to the most complex troubleshooting issues, novel situations and oversees the delivery of training and coaching.
为复杂问题、新情况提供监督和支持，并监督培训和辅导的实施
- Uses expert knowledge to support regulatory inspections where required.
监管机构检查时，提供必要的专业知识支持
- To maintain / improve efficient microbiological analytical procedure to ensure it is maintained at a high-quality standard.
维护/改进有效的微生物分析检验程序以确保高质量标准
- Has a direct involvement in regulatory inspections.
直接参与内外部法规审计
- Provides microbiological expert knowledge and support to the complex troubleshooting issues, novel situations and oversees the delivery of training and coaching.
提供微生物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
Continuous Quality Improvement
持续质量改善
- Maintain / Improve lab procedure, secure operation GMP compliance.
维护/改进微生物实验室流程，确保高度的GMP 符合性
- Identify the quality and compliance gap and work out improvement plan with area manager.
识别质量合规风险，协同相关部门制定改进计划
People management
人员管理
- Lead and provide guidance in the daily job of the team.
领导和指导团队的日常工作
- Build and develop team and personnel capability.
建立和提升团队和人员的能力
- Optimize performance outcomes of direct reports and ensure high quality IDP review.
辅导员工绩效目标的达成和改善，并确保高质量的员工发展计划
SHE
安全环境健康
- Identify and understand the SHE risks 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。
Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力
Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Microbiology.
大学本科以上学历，药学或微生物等相关专业毕业
• Experience in GXP environment of pharmaceutical industry
制药行业工作经历
• 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 Microbiological technologies or in quality control on Microbiological experience
微生物技术领域和微生物质量控制经验
• 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 Microbiological lab including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology.
能够为微生物实验室在仪器管理、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
• Finance budget and controlling
财务计划和控制
• 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.
