Senior IT BA
再鼎医药（上海）有限公司
- 公司规模：500-1000人
- 公司性质：外资（非欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2020-11-14
- 工作地点：上海-浦东新区
- 招聘人数：1人
- 工作经验：3-4年经验
- 学历要求：本科
- 职位月薪：1.5-2.5万/月
- 职位类别：网络工程师(IT工程师)
职位描述
主要职能 Primary Function:
? Project responsibilities:
Act as IT PM role for conducting application implementation project including evaluation of capability of vendor, product and service, coordination with vendor and business functions to ensure .
? Operation responsibilities:
Act as system manager role for managing security configuration e.g. access control, system configuration e.g. template, business flow, configurable functionality, report generation.
Handle routine quality activities e.g. change control, deviation, CAPA, computerized system validation and computerized system quality management according to SOPs, guidelines and regulations.
主要职责 Major Responsibilities and Duties:
1. Act as primary IT contact in respective function area.
2. Identify new system demand by fully understanding business objective, business requirement, standard and regulation.
3. Ensure system stability and data integrity.
4. Take accountability to maintenance high level of customer satisfaction.
5. Play a key role on identifying continuous improvement opportunity on responsible function area.
6. Provide supporting on validation, testing and installation for assigned function area system.
7. Ensure managed system operation aligned with requirement of IT and information security standards.
8. Identify root cause of application problem and avoid recurrences.
9. Design, develop and provide user training for responsible systems, include maintaining training manuals.
10. Build close collaboration with key internal& external stakeholder.
11. Perform application administration on assigned system.
12. Provide input on demand requirement for creation and maintain IT investment plan.
职位要求：
Skills:
? 3+ years of experience working in a pharmaceutical or regulated environment
? Must have experience working on IT Systems in a regulated environment
? Hands-on experience in implementing, management and validation of GxP computerized systems
? Specific system administration experience in clinical, R&D, RA and PV business is preferred，such as CTMS, eTMF, PV, eCTD etc.
? Strong understanding of regulations (NMPA/FDA/EMA) and guidelines(GAMP)
Education:
? Bachelor’s Degree in Computer Science or relevant
? Good spoken and written English skills
Base location:
Shanghai
? Project responsibilities:
Act as IT PM role for conducting application implementation project including evaluation of capability of vendor, product and service, coordination with vendor and business functions to ensure .
? Operation responsibilities:
Act as system manager role for managing security configuration e.g. access control, system configuration e.g. template, business flow, configurable functionality, report generation.
Handle routine quality activities e.g. change control, deviation, CAPA, computerized system validation and computerized system quality management according to SOPs, guidelines and regulations.
主要职责 Major Responsibilities and Duties:
1. Act as primary IT contact in respective function area.
2. Identify new system demand by fully understanding business objective, business requirement, standard and regulation.
3. Ensure system stability and data integrity.
4. Take accountability to maintenance high level of customer satisfaction.
5. Play a key role on identifying continuous improvement opportunity on responsible function area.
6. Provide supporting on validation, testing and installation for assigned function area system.
7. Ensure managed system operation aligned with requirement of IT and information security standards.
8. Identify root cause of application problem and avoid recurrences.
9. Design, develop and provide user training for responsible systems, include maintaining training manuals.
10. Build close collaboration with key internal& external stakeholder.
11. Perform application administration on assigned system.
12. Provide input on demand requirement for creation and maintain IT investment plan.
职位要求：
Skills:
? 3+ years of experience working in a pharmaceutical or regulated environment
? Must have experience working on IT Systems in a regulated environment
? Hands-on experience in implementing, management and validation of GxP computerized systems
? Specific system administration experience in clinical, R&D, RA and PV business is preferred，such as CTMS, eTMF, PV, eCTD etc.
? Strong understanding of regulations (NMPA/FDA/EMA) and guidelines(GAMP)
Education:
? Bachelor’s Degree in Computer Science or relevant
? Good spoken and written English skills
Base location:
Shanghai
职能类别：网络工程师(IT工程师)
公司介绍
Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.
再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。
再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。
联系方式
- 公司地址：地址：span上海浦东张江高科技园区金科路4560号金创大厦3号楼8楼