锦鲤求职岗位描述
岗位职责
岗位目的:
负责创建，维护，运营以及持续改进公司质量管理体系，确保符合美国FDA，欧盟EMA，中国药监局以及其他目标市场特有的法规要求。建立，维护以及持续优化质量管理体系相关的电子管理系统，包括不限于偏差/调查/纠正预防措施/变更管理，技术培训系统，以确保质量管理系统的运营简单精益有效。定期监控，分析，追踪，趋势分析工厂或者业务部门的运营质量相关的绩效。
Be responsible for creation, maintenance, operation and continuous improvement of the corporate Quality Management System, ensure GxP requirements in compliance with Food Drug Administration (FDA) of USA, European Medicine Agency (EMA), China National Medical Products Administration (NMPA) and other target market specific regulations. Build up, maintain and continuous optimize Quality Management System related electronic-system, including but not limited to deviation/investigation/CAPA/Change Control, technical training system to enable QMS operation simplified and operation excellent for the whole company. Regular monitor, analyze, tracking, trending site or business function’s operation quality related performance.
主要工作职责:
主要工作一：集团药品质量管理要求Corporate PQS Requirements
具体职责：
1、密切沟通和跟踪药品质量管理体系在现场和业务部门的实施和运行。持续改进已建立的质量管理体系文件。
Close communication and tracking implementation and operation of Pharmaceutical QMS in sites and business functions. Execute the continuous improvement of established QMS documentations.
2、在工厂、公司业务职能部门就问题和流程机会等方面促进和有效地与专业专家(SME)进行沟通
Facilitate and effective communication with master Subject Matter Expert （SME）from site, corporate business functions for burning issues, opportunity of process.
3、当外部法规、行业惯例、主要权威机构要求发生任何可能影响公司合规和运营的变化时，主导法规差距分析，和关键利益相关方制定缓解行动方案。监控行动方案的落实。
Facilitate regulation gap analysis and mitigate actions with key stakeholders when external regulations, industry practice, key authority agency requirements have any change which may impact on Corporate compliance and operation. Monitor implementation of those mitigate actions.
4、踪和趋势网站实施计划，直到其完成。对于高风险项目，逐步升级到管理评审会议。
Tracking and trending site implementation plan until its completion. With respect to high risk item, escalate to management review meeting.
5、作为2-3个质量模块相关课题的SME，领导现场和业务功能的培训和指导，以及支持外部检查，如数据完整性，文件和记录，偏差。
As SME for 2-3 Quality module related topics, leading training and coach for site and business function, as well as support external inspections, e.g. Data integrity, documentation and records, deviation.
6、协助和管理外部服务供应商/承建商/顾问，为工厂/业务部门提供专业知识。
Facility and manage the external service providers/contractors/consultants, to contribute their professional knowledge transfer to site/business function SME.
主要工作二：质量审计 Quality Audit
具体职责：
1、在技术性卓越的生产环境中对质量和合规系统进行独立评估
Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings
2、对化学品、包装组件、成品制剂或委托服务供应商进行复杂且高要求的国内和国际审计。 根据cGMP、ISO标准、PIC/S、ICH Q7A和公司规程进行审计。
Performs complex and demanding domestic and international audits of suppliers of chemicals, packaging components, finished drug products, or contracted services. Audits are conducted in accordance with cGMPs, ISO Standards, PIC/S, ICH Q7A and company procedures.
3、计划、协调和执行复杂内部新建工厂的计划或计划外cGMP核查，以确保符合cGMP和公司标准
Plans, coordinates and conducts scheduled or unscheduled cGMP audits of complex internal lnnovent Sites to ensure compliance to cGMPs and company standards.
4、提供清晰、科学/技术上合理的解释，支持任何审计发现和纠正和预防措施
Provide clear and scientifically/technically justified interpretations and support for any audit findings and proposed corrective and preventive actions.
5、跟踪审计缺陷，审核审计发现项的整改措施或反馈，确保其符合信达的质量要求和信达的期望
Follow up all the audit findings, review the supplier CAPA/responses to ensure its meet with Innovent quality requirement and expectation
6、确保所有的审计文件被适当的归档，包括审计计划，报告，预防和整改和其他。
Ensure all the audit documents are archived accordingly includes audit agenda, report, CAPA and others
7、开发和解释审计发现项，以沟通趋势并提供建议，以积极主动的方式解决这些发展趋势
Initiate and maintain close contacts with industry/professional organizations to keep aware of trends and initiatives in quality assurance, GMP compliance and inspections.
8、在保持独立性的同时，与其他QA同事紧密合作以确保对CGMP的通常理解和开发中的解释
While maintaining independence, work closely with other QA colleagues to assure common understanding of developing interpretations of CGMP
主要工作三：其他Other
具体职责：
1、导入和推广质量文化和活动，确保行为符合公司/质量推广文化。
Induction and promotion of Quality Culture and activity, ensure behaviors align with Corporate/quality promoted culture.
2、在需要时支持外部检查。
Support external inspection when needs.
3、主管交办的其他工作。
Other duties as assigned by supervisor
岗位要求
学历及专业：
本科或硕士学历；本科至少5年，硕士至少3年，专业不限；
Bachelor (minimum 5 years) or master(minimum 3 years) degree. no professional limitation
专业知识：
详细了解美国，EMA，中国和国际法规和GxP的指导文件，以及行业惯例，如PDA, PIC/S, ISPE。
Detailed understanding of US, EMA, China and International regulations and guidance documents for GxP, as well as industry practices, e.g. PDA, PIC/S, ISPE.
工作经验：
生物技术/制药公司质量保证GxP经验;
Quality Assurance GxP experiences in biotech/pharmaceutical companies.
有全球药品运营、质量、项目管理经验者优先;
GxP experiences of global pharmaceutical operations, quality, project management in global environment preferred.
有在初创公司和/或中小型企业创建和开发质量体系环境的实际经验者优先;
Hands on experience in creating and developing Quality System Environments at startup and/or small/middle sized companies preferred.
有管理其他全职员工和/或承包商/顾问的经验;
Experiences managing other full-time employees and/or contractors/consultants.
技能要求：
熟悉微软办公软件及其他计算机系统的基本操作技能;
Familiar with Microsoft offices and other basic computer system operation skills.
优秀的人际关系、口头和书面沟通能力;
Excellent interpersonal, verbal, and written communication skills.
优秀的项目管理技能，能够管理多个项目，并严格按照时间表执行。
Strong project management skills with ability to manage multiple projects and execute in adherence to timelines.
其他要求：
需要时能够适应国内和国际出差。
Ability to travel domestically and internationally as required.