QA Specialist

Responsibilities:

主要职责：

Primary Function基本职能

To assist QA Manager to conduct QA oversight within Wusi site, review and approve GMP documents to ensure that all aspects of manufacturing activities comply with cGMP, legal and regulatory requirements and with the headquarters Quality Standards.

协助QA经理在五四工厂进行QA监督，审核和批准GMP文件，以确保生产活动的所有方面符合cGMP法律法规要求和Elanco动物保健质量标准。

Primary Accountabilities/Responsibilities 基本职责

Manage and maintain deviation and CAPA management comply with global procedures and GMP guideline, ensure deviation and CAPA activities disposed timely.管理和维护偏差和CAPA管理符合全球程序和GMP准则，确保偏差和CAPA活动得到及时处理。Manage and maintain change control management comply with global procedures and GMP guideline, ensure change control activities disposed timely.管理和维护变更控制符合全球程序和GMP准则，确保变更控制活动及时进行。Manage and maintain deviation, change control and CAPA modules in computer system.管理和维护计算机系统中的偏差，变更和CAPA模块。Manage and maintain reprocess and rework management comply with global procedures and GMP guideline, ensure reprocess and rework activities disposed timely.管理和维护再加工和返工管理符合全球程序和GMP准则，确保再加工和返工活动及时处理Review Validation/Qualification Protocol and Report, draft and review quality risk assessment.审核验证/确认方案和报告，起草和审核质量风险评估Act as a partner with the production department to review related procedures, participate in projects and related investigation.与生产部一起审查相关程序，参与项目和相关调查。Perform review of GMP related documents (formulation and pesticide batch records, raw material analytical record, etc.) to ensure batch release timely.对GMP相关文件(配制和农药批记录，原料分析记录等)进行审核，确保及时放行。Maintain quality data in SAP system to ensure it is correct and meets demand.维护SAP的质量数据，确保数据正确和满足需求。Timely writing and complete GMP relevant documents in own area: ; Procedure, PQRs, annual review, Report, etc.及时编写并完成本区域GMP相关文件:如SOP, PQRs，年度回顾，报告等Conduct on-site QA inspection, Gemba Walk and 5S management.进行现场QA检查、实地巡检和5S管理。Any other tasks assigned.其他分配的任务。

Qualification资格

BS degree above in Chemistry, Bioengineering, Food, Pharmacy or relevant discipline; Desirable: MS or equivalent化学、生物工程、食品、制药或相关专业本科以上学历；理想职位：硕士或同等学历At least 3 years’ of experience in pharmaceutical or relevant industry ( quality, laboratory, manufacture).至少3年制药或相关行业工作经验(如质量，实验室，生产)Experience in EU GMP and ICH guidelines and manufacture is a plus.有EU GMP和ICH指南和生产经验者优先Experience in internal/external audit is a plus.有内部/外部审计经验者优先

Skills & Knowledge技能和知识

Fluent in English and Chinese (both written and spoken).中英文流利(书面和口语)Excellent interpersonal skills and able to network effectively across groups and levels.优秀的人际交往能力，能够有效地与不同群体和不同级别的人沟通Ability to work under pressure and compliance with strict deadlines.能够在压力下工作，并遵守严格的期限Ability to priorities or work with conflicting priorities.有能力处理优先事项或有冲突的优先事项Ability to attend meeting in different time zone有能力参与不同时区会议Advanced knowledge of MS Excel, Word, PowerPoint.熟练使用MS Excel, Word, PowerPoint

Core competencies核心竞争力

Influence: Builds relationships and influences internal and external customers, Team player.影响力：建立关系并影响内部和外部客户，具有团队精神Accountability: Accountable for Results, Good multiple-tasking focus, Strong follow through and closure of matter/case.责任心：对结果负责，能够同时完成多项任务，有很强的跟进和完成能力Working Style: Persistence and Stability, Results Orientation, High learning agility, Proactive and fast response/having sense of urgency, Attention to details and adherence to guidelines.工作风格：坚持性和稳定性，结果导向，高学习敏捷性，积极和快速的反应/有紧迫感，注意细节和遵守指导方针Personal Brand: Resourceful, Assertive, Self-motivated, Energetic.个人品牌：足智多谋，自信，自我激励，精力充沛

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