DS Technical Support Manager DS 技术支持经理

20-40万元/年

广州市本科及以上

刷新时间：2021-04-27

职位描述

1.Manage Quality Systems (Deviations, CAPA, Change Control, Audit Observation) response timelines and metrics.

管理DS部门质量系统包括偏差，CAPA，变更，审计发现项的行动时限及评估指标。

2.Responsible for revision to SOP, WI, and any associated documents in DS.

负责DS部门SOP，作业指导书及相关文件的修订。

Responsible for scheduling and management of Preventative and Corrective Maintenance activities.

负责规划及管理部门预防及纠正维护等活动。

3.Develop and maintain DS finite-schedule which includes direct and in-direct activities.

发起及跟进DS部门直接及非直接活动相关的定时计划。

4.Responsible EH&S Activities responses and metrics.

负责环境健康安全相关活动及评估指标。

5.Responsible for management of DS SAP entry and raw material coordination activities.

负责DS物料SAP录入及原材料相关协调处理活动。

6.MES recipe development and maintenance of recipes.

MES处方管理及维护。

6.Cooperate with related department, MST department, process department, engineer department, QA, QC and warehouse department in a good manner.

与相关部门，技术转移、研发、工程、QA、QC和仓库等部门保持良好的沟通协作。

7.Additional projects as needed to further the progress of DS Manufacturing.

DS部门未来发展相关的项目管理。

8.Develop the tactical vision to manage the overall metrics of DS quality systems (Deviations, CAPA, Change Controls, and Quality Audits), Batch Record Review, Preventative and Corrective Maintenance, EH&S activities, Finite-Schedule, DS SAP / Raw Material Coordinator, MES Recipe development and maintenance, and additional projects as needed or required.

负责DS团队的质量体系(偏差，CAPA，变更和质量审计)、批记录审核，预防和纠正、EHS活动,Finite-Schedule, DS SAP /原材料协调员, MES配方开发和维护等,并根据需要额外的项目或要求。

9.The individual will develop, manage and lead the above-mentioned functions while working in partnership with Quality Assurance, Quality Systems, Quality Control, Manufacturing, Engineering, Manufacturing Science & Technology, and CMC to ensure the highest possible quality compliance and safety outcome for Drug Substance. This role will ensure Drug Substance has a robust and effective management system, processes and methods are in alignment with Site requirements and will utilize metrics to continually improve quality and safety.

个人将开发,管理和领导工作时上述功能与质量保证,质量体系,质量控制、制造、工程、科技、制造业和CMC以确保最高的质量要求和安全结果药物物质。这一角色将确保药物有一个健全和有效的管理系统，过程和方法符合现场要求，并将利用指标不断提高质量和安全性。

10.Any other assignment as is determined by supervisor.

完成上级安排的其他工作。
1.Bachelor or above degree in Pharmacy, Biology or Chemistry; alternatively.

本科或以上学历，药学，生物学或化学专业。

2.Familiar with quality activities in manufacturing shop floor, including cell culture and purification technology, deviation, change control, validation, equipment qualification, etc.

熟悉生产现场的质量活动及生物制药生产工艺包括细胞培养，纯化技术，偏差，变更，验证和设备确认等。

3.Familiar with the regulatory requirement of CFDA cGMP、EU cGMP、PIC/S cGMP and FDA cGMP.

熟悉CFDA cGMP、EU cGMP、PIC/S cGMP及FDA cGMP的要求。

4.CET-4 or advance qualification, good command in written an oral English.

英语四级以上，良好的英语书写和口语能力。

5.Familiar with the Office software like the Word, Excel.

熟练掌握Word, Excel 等Office办公软件。

6.PMP is preferred.

持有项目管理专家资格证者优先考虑。

其他要求

招聘人数：1人
职能类别：生产技术员

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。