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