Analytical Group Manager (QC)
Own the overall performance of an analytical group in Safety, Quality, Supply, Cost and People area. Drive continuous improvement to achieve high performance and competitivity to business.
负责分析测试团队在安全、质量、供应、成本和人员方面的整体绩效表现。推动持续改进，以实现高性能和业务竞争力。
Job Responsibilities
工作职责
Routine work
日常工作
- Establish optimal operation pattern in the analytical group and build high efficient team to achieve top decile productivity target
在分析测试团队建立合理的工作模式，建立高效的团队以达成检测效率十分位的目标
- Manage routine analysis for products and materials to deliver accurate test results in a timely manner.
日常的产品物料检验管理，确保及时放行
- Establish, develop and manage products and materials test system to make sure that quality of product meets internal and regulatory requirements.
- Ensure schedule adherence for analytical samples, Deviations and CAPAs, Change controls and Change action items, Lab Investigations, special projects
确保样品分析、偏差调查、实验室调查、纠偏预防措施、变更及行动项和特别项目的按时完成和交付
- Organize group tier meetings, and conduct layered audit and relevant process confirmation to ensure timely exposure/escalation of risks/issues.
组织团队层级会议，并进行分层审计和相关流程确认，以确保及时暴露/上报风险/问题
- Regulatory/change assessment related to analytical process
分析测试相关的法规和质量变更的评估
- Technical review and approval of technology transfer and method validation/verification
技术转移和分析方法验证/确认的一线审阅和批准
- Establish optimal operation pattern in the analytical group and build high efficient team to achieve top decile productivity target
在分析测试团队建立合理的工作模式，建立高效的团队以达成检测效率十分位的目标
- Manage routine analysis for products and materials to deliver accurate test results in a timely manner.
日常的产品物料检验管理，确保及时放行
- Establish, develop and manage products and materials test system to make sure that quality of product meets internal and regulatory requirements.
- Ensure schedule adherence for analytical samples, Deviations and CAPAs, Change controls and Change action items, Lab Investigations, special projects
确保样品分析、偏差调查、实验室调查、纠偏预防措施、变更及行动项和特别项目的按时完成和交付
- Organize group tier meetings, and conduct layered audit and relevant process confirmation to ensure timely exposure/escalation of risks/issues.
组织团队层级会议，并进行分层审计和相关流程确认，以确保及时暴露/上报风险/问题
- Regulatory/change assessment related to analytical process
分析测试相关的法规和质量变更的评估
- Technical review and approval of technology transfer and method validation/verification
技术转移和分析方法验证/确认的一线审阅和批准
- Technical review and approval of technical assessment report
技术评估报告一线审阅和批准
- SME of core analytical process
担任核心分析测试流程专家的角色
- Rational budgeting for analytical group resources, like investment, expenditure and headcount, and achieve finance target
分析测试团队资源的合理预算，如资金投入，支出及人数管理，并达成财务目标
- Other Project/task assigned upon business needs
- 完成其他业务驱动的项目和任务
Team Management
日常管理
- Lead and provide guidance in the daily job of the team.
领导和指导团队的日常工作
- Set clear direction and objectives and motivate and encourage all staff
制定明确的方向和目标，激励和鼓励所有员工
- 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
- Own people performance development of the analytical group
负责分析测试团队的人员绩效发展
- Develop all kinds of skills in relation to work field and pursue continuous improvement
发展各种工作技能并追求持续的改进
GMP compliance
GMP 符合性
- Ensure compliance of analytical group with GMP, GLP, corporate standards or regulatory
确保分析测试团队在GMP，GLP，企业标准及法规上的合规性。
- Support self-inspection and coordinate audits from authority or GQA
协助自检以及协调外部官方或GQA审计
S.H.E. Responsibilities
SHE 职责
- Promote a SHE focussed culture to achieve excellent SHE target
提升安全至上的文化氛围，达成卓越的SHE目标。
- Implement SHE Policy and Standards and ensure compliance with local legislation at daily work
执行SHE政策及标准以确保日常工作中的与当地法规的符合性
- Proactively identify SHE risks and take appropriate action
主动识别SHE风险并适时采取合适行动
- Seek suitable method and technology to address the SHE risks or issues
利用合适的方法和技术阐明SHE风险及事件。
- Solve all SHE problems and communicate with SHE team
解决所有SHE方面问题，和SHE团队保持沟通
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, Biology, Chemistry.
大学本科以上学历，药学、化学分析或相关专
业毕业
- Has experience in pharmaceutical quality control lab.
具备制药质量控制实验室的工作经历
- Sound knowledge of the analytical work
良好的分析测试知识
- Sound knowledge of the principles and concepts of Good Manufcaturing Practice/ Good Laboratory Practice.
对GMP和GLP的原则和概念有充分的了解。
- Sound knowledge and understanding of SHE principles
对SHE的原则和概念有充分的了解。
- Sound knowledge in analytical transfer and validation, related experience is preferred.
- Sound knowledge of main global pharmacopoeia and relative regulations.
具有全球主流药典和其他相关法规的知识。
Capabilities
能力
- Functional mastery of written and spoken English
- 熟练掌握书面和口语英语
- Proficient in time management
- 精通时间管理
- Good computer skill
良好的计算机能力 - Good communication skills with strong responsibility
- 良好的交流沟通能力，强烈的责任心
- Good people management skills
- 良好的人员管理技能
- Competent in problem solving and risk analysis
- 能够进行问题解决和风险分析
- Mastery of risk/issue escalation skills
- 掌握风险和问题上报技能
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.
