Analytical Group Manager (QC)

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  • 江苏省-无锡

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