职位描述
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 complianceGMP 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. ResponsibilitiesSHE 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
