上海 [切换城市] 上海招聘上海生物/制药/医疗器械招聘上海生物工程/生物制药招聘

文件管理员 document Clerk

上海合全药物研发有限公司

  • 公司规模:500-1000人
  • 公司性质:合资
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2019-04-05
  • 工作地点:上海-浦东新区
  • 招聘人数:1人
  • 工作经验:无工作经验
  • 学历要求:本科
  • 职位月薪:4-6千/月
  • 职位类别:生物工程/生物制药

职位描述

  1. 全面负责生产部事务。管理和协调各组以提供高质量的产品,以有竞争力的价格和准时供货满足国内和国外客户的需求。保证生产过程、生产文件和CGMP符合性,满足客户质量期望,确保生产活动符合CGMP法规要求。responsible for all site quality matters.Be responsible for managing andcoordinating the manufacturing units to supply products in good quality,competitive cost and on time to internal and external customers.Ensure productquality and cGMP compliance,meet clients quality expectation.Ensure that thequality activities comply with CGMP requirement.
  2. 领导整个生产部门按照规范进行生产,例如GMP(质量管理规范)和客户指定要求。responsible for providing leadership for best business practices such as GMP(good manufacturing practice)and customer specific in the whole productiondepartment.
  3. 推进积极向上的文化,在高度发展的环境中提高质量和效率。培养有潜能的员工并为之提供职业规划。iciency in a highly motivated environment.And also responsible for identifyingthe collaborators with high potential and preparing career plans for them.
  4. 批准生产文件和生产批次记录。prove quality procedures and production batch records.
  5. 根据项目计划,安排生产活动。range production activities according to project planning.
  6. 组织相关的偏差调查,并执行改进计划或CAPAganize correlative deviation investigation,and execute improvement plans orCAPA.
  7. 执行客户质量协议,满足客户质量期望。ecute the client quality agreement,meet client's quality expectation.
  8. 配合QA进行客户审计和政府检查,进行报告回复,进行发现项的整改。operate with aA to conduct client audit and authorityinspection,respond reportand correct the observations.
  9. 复核验证计划,并组织生产员工配合验证工作。view the verifcation plan and organize the production staf to cooperate wihthe verification.
  10. 组织生产部员工培训,提升员工质量意识和公司GMP文化。ganize quality training,promote employee quality awareness and companyGMP culture.
  11. 定期安排EHS培训,监督和确保所有员工在日常工作中遵守安全操作规程。ganize EHS training regularly,supervise and insure all stuff follow the safeoperation procedure in daily work.
  12. 配合协调其他相关工作,如预防维护、新设备采购、环境监控。ordinate with other related work,such as preventive maintenance,new equipmentpurchase,environmental monitoring.
  13. 对设备产能,劳动力及生产成本进行评估,制定周计划,确保销售需求。nsidering capacity of facility and equipment,labor force and production cost,making weekly plan for packaging or sterile production area to meet requirement
  14. 监控生产过程,生产环境以及GMP执行情况,确保整个生产运作处于监控状态。

    Lead and manage the team to carry out inspect the manufacture process,production environment,and GMP     compliance to ensure the whole manufactureoperation under control.

岗位要求:

1.本科及以上学历

  Bachelor degree or above

2.直接与制药学相关的经历或者培训,或者其他等同的经历。

Directly-related science discipline with experience or training in             pharmaceutical industry or equivalent experience.

3.具有英语学习经历,或者良好的英语听说读写能力。

 Have English training experience or good in English speaking, writing,  reading and also listening.

4.较强的交流与协作能力及写作与口语能力,杰出的人际交往能力。

  Strong communication and coordinate skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.

5.在文件管理方面具有1年以上的工作经验优先

  Preferred 1 year working experience about document management.

6.在剂型/制剂开发和过程开发方面有培训经历或工作经验者优先。

  Preferably be trained and have experience in formulation/dose development & process development.

7.具有对新员工进行的常规培训的能力及文件组织更新能力。

  Ability for general training of new staff and organize and update document.

8.具有团队精神,能完成绩效目标。

  Be able to work in a team-oriented manner in order to accomplish  performance objectives.


公司介绍

合全(sta)是药明康德全资子公司,其中包括:上海合全药物研发有限公司( 原药明康德工艺研发部,上海外高桥),合全药物公司是sta 专门从事工艺合成路线研发及放大实验的研发团队;合全药业金山公司和常州公司是sta 提供符合cgmp 标准的中式放大及商业化生产的基地。
shanghai syntheall pharmaceutical co., ltd. is a wholly-owned subsidiaries of wuxi app tec, including:
sta r&d is professional in route selection and process scaled up r&d;sta jinshan and changzhou are the pilot plants and commercial production base under cgmp.

sta 公司愿景 sta vision:
改变创新药api 的工艺研发和生产模式,加快新药研发速度,降低新药成本,造福人类健康。
transform how industry develops and manufactures apis, shorten the time and lower the cost of new drug developments, improve the quality of life.

sta 公司使命 sta mission:
不断创新、不断完善创新药api 的工艺研发以及研发和商业化生产的一体化平台,为全球新药研发机构提供最优质***效的api 工艺研发和生产一体化服务和***解决方案。
constantly enhance the capabilities of our fully-integrated api development and manufacturing platform from preclinical batches to commercial supplies, provide highly efficient and cost-effective solutions to our partners worldwide.

联系方式

  • 公司地址:富特中路288号