職位描述
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.負責分析測試團隊在安全、質量、供應、成本和人員方面的整體績效表現。推動持續改進，以實現高性能和業務競爭力。Job Responsibilities工作職責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在分析測試團隊建立合理的工作模式，建立高效的團隊以達成檢測效率十分位的目標 * Manage routine analysis for products and materials to deliver accurate test results in a timely manner.日常的產品物料檢驗管理，確保及時放行 * 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確保樣品分析、偏差調查、實驗室調查、糾偏預防措施、變更及行動項和特別項目的按時完成和交付 * Organize group tier meetings, and conduct layered audit and relevant process confirmation to ensure timely exposure/escalation of risks/issues.組織團隊層級會議，并進行分層審計和相關流程確認，以確保及時暴露/上報風險/問題 * Regulatory/change assessment related to analytical process分析測試相關的法規和質量變更的評估 * Technical review and approval of technology transfer and method validation/verification技術轉移和分析方法驗證/確認的一線審閱和批準 * Establish optimal operation pattern in the analytical group and build high efficient team to achieve top decile productivity target在分析測試團隊建立合理的工作模式，建立高效的團隊以達成檢測效率十分位的目標 * Manage routine analysis for products and materials to deliver accurate test results in a timely manner.日常的產品物料檢驗管理，確保及時放行 * 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確保樣品分析、偏差調查、實驗室調查、糾偏預防措施、變更及行動項和特別項目的按時完成和交付 * Organize group tier meetings, and conduct layered audit and relevant process confirmation to ensure timely exposure/escalation of risks/issues.組織團隊層級會議，并進行分層審計和相關流程確認，以確保及時暴露/上報風險/問題 * Regulatory/change assessment related to analytical process分析測試相關的法規和質量變更的評估 * Technical review and approval of technology transfer and method validation/verification技術轉移和分析方法驗證/確認的一線審閱和批準 * Technical review and approval of technical assessment report技術評估報告一線審閱和批準 * SME of core analytical process擔任核心分析測試流程專家的角色 * Rational budgeting for analytical group resources, like investment, expenditure and headcount, and achieve finance target分析測試團隊資源的合理預算，如資金投入，支出及人數管理，并達成財務目標 * Other Project/task assigned upon business needs * 完成其他業務驅動的項目和任務Team ?Management日常管理 * Lead and provide guidance in the daily job of the team.領導和指導團隊的日常工作? * Set clear direction and objectives ?and motivate and encourage all staff制定明確的方向和目標，激勵和鼓勵所有員工 * Optimize performance outcomes of direct reports and ensure high quality IDP review?????? 輔導員工績效目標的達成和改善，并確保高質量的員工發展計劃 * Own people performance development of the analytical group負責分析測試團隊的人員績效發展 * Develop all kinds of skills in relation to work field and pursue continuous improvement發展各種工作技能并追求持續的改進GMP complianceGMP 符合性 * Ensure compliance of analytical group with GMP, GLP, corporate standards or regulatory確保分析測試團隊在GMP，GLP，企業標準及法規上的合規性。 * Support self-inspection and coordinate audits from authority or GQA協助自檢以及協調外部官方或GQA審計S.H.E. ResponsibilitiesSHE 職責 * Promote a SHE focussed culture to achieve excellent SHE target提升安全至上的文化氛圍，達成卓越的SHE目標。 * Implement SHE Policy and Standards and ensure compliance with local legislation at daily work執行SHE政策及標準以確保日常工作中的與當地法規的符合性 * Proactively identify SHE risks and take appropriate action主動識別SHE風險并適時采取合適行動 * Seek suitable method and technology to address the SHE risks or issues利用合適的方法和技術闡明SHE風險及事件。 * Solve all SHE problems and communicate with SHE team解決所有SHE方面問題，和SHE團隊保持溝通Education, Qualifications, Experience and Capabilities 教育、資質、經驗和能力 * Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry.??????? 大學本科以上學歷，藥學、化學分析或相關專??????? 業畢業 * Has experience in pharmaceutical quality control lab.????? 具備制藥質量控制實驗室的工作經歷 * Sound knowledge of the analytical work????? 良好的分析測試知識 * Sound knowledge of the principles and concepts of Good Manufcaturing Practice/ Good Laboratory Practice.?????? 對GMP和GLP的原則和概念有充分的了解。 * Sound knowledge and understanding of SHE principles?????? 對SHE的原則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.????? 具有全球主流藥典和其他相關法規的知識。Capabilities 能力 * Functional mastery of written and spoken English * 熟練掌握書面和口語英語 * Proficient in time management * 精通時間管理 * Good computer skill良好的計算機能力 * Good communication skills with strong responsibility * 良好的交流溝通能力，強烈的責任心 * Good people management skills * 良好的人員管理技能 * Competent in problem solving and risk analysis * 能夠進行問題解決和風險分析 * Mastery of risk/issue escalation skills * 掌握風險和問題上報技能
