杭州招聘

Job Purpose (State in one sentence the overall objective of the role)
职位设定的目的（用一语句描述该职位的总的工作目标）

主要负责病毒原液车间和西山动物房生产工序及其附属区相关域各工序，确保进行有效监督，审核产品批记录和QC结果，及时反应和解决问题，确保生产工序各方面均符合法规、GMP要求和诺华质量手册的要求。
Primarily responsible for providing MQA support to all workshops, by ensuring effective supervision outside of normal working hours, and timely response and problem resolution. Ensure all aspects of the manufacturing processes are in accordance with regulations, GMP requirements and applicable Novartis quality manual requirements.

Major Accountabilities(Describe the 5-7 main results of the role to be achieved)
主要职责内容（5-7个主要职责）

1. 主要负责病毒原液车间和西山动物房各工序的生产流程，通过有效的文件检查和监督确保生产过程受控并在适当的标准下有效运行。
1. Primarily responsible for providing MQA support to all workshops, through effective document review and supervision to ensure production processes are controlled and applicable standards are adhered to.
2. 支持所有生产区域的生产QA监督，如分装，灯检，贴标，包装，QC、成品发货、原料库和公共设施来确保连续QA车间监督。
2. Support MQA supervision of all production areas such as Filling, Visual Inspection, Labelling, Packaging, QC , finished product delivery, raw materials warehouse,and Utilities to ensure continuous QA ShopFloor oversight.
3.在跨部门团队工作，提供正式的文件反馈和即时反馈及指导，至少花50%的时间在车间，实时完成批记录检查，和生产车间一起创建一种开放、易交流的文化氛围。
3. Work in cross-functional teams, provide formal documented feedback as well as immediate feedback and coaching, spend a minimum of 50% of time on the Shopfloor, perform real-time batch record review, and create an open and communicative culture with manufacturing/support areas.
4．支持和批准偏差调查，确保进行有效的根本原因调查和准确评估受影响的产品的质量。识别重复偏差，确保实施合适的CAPA。确保对偏差进行趋势追踪，以便QA监督管理。
4. Provide support for and approve deviation investigations, ensuring effective root cause investigations are performed and product quality implications are accurately assessed. Identify repeat deviations and ensure appropriate CAPAs are implemented. Ensure trending of deviations to target increased QA oversight.
5．对QC进行QA监督，包括文件和检测结果的审核，检查和审核细菌类原液生产区域的的环境监测结果，评估不良趋势或偏差调查。
5. Provide QA oversight for QC via document/result review, inspection and review of Environmental Monitoring of viral bulk areas and warehouse to assist with negative trends or deviations.
6.协助修订所有与病毒原液生产过程和西山动物房有关的文件（如:SOPs,BPRs），来确保有恰当的细节和说明来指导车间的生产活动。
6.Assist in the revision of all documentation (e.g.SOPs, BPRs) to ensure that there is appropriate detail and instruction for correct Shopfloor execution.
Key Performance Indicators (Indicate how performance for this role will be measured)
KPI绩效指标(绩效目标主要衡量指标)

1.. 有能力跨团队工作；Competent cross-functional team work
2. 胜任各区域的质量监督；Competent quality oversight provided to areas
3. 提升积极的品质文化；Promotes a positive quality culture
4. 实行QA车间工作；Implements QA Shopfloor working
5.问题处理周全性；Deals with problems suitably
6.外部评价；External evaluation

浙江天元生物药业有限公司 诚聘