北京招聘

职位描述：

工作职责：

1. Assessment and implementation of Fresenius
Kabi global quality requirements applicable to I&DC.

2. Coordinate general
QA-systems, e.g. Validation and Qualification (validation of procedures,
qualification of equipment)/Training (initial training of new employees,
periodic training)/SOP-system/Change Control and Deviation/Quality Risk
Management/Self-Inspections (perform internal audits in regular intervals)/Vendor
Qualification/ Continuous improvement process /corrective/preventive actions,
quality management review)/Technology Transfer process

3. Close interaction with Analytical Development
and Formulation Development department and Regulatory.

4. Maintain the equipment and system, be sure
them in period of calibration validity and good operation situation before
use. Collect, formulate and help to perform annual preventive maintenance
plan. Check the usage record of the equipment.

5. Assist IQ/OQ/PQ, annual calibration/qualification
of the equipment in I&DC center.

6. Experimental data and record reviewing, make
sure their reality, normal, and meet the requirements of quality assurance
and submission to authority (e.g. cFDA, EMA).

7. Be responsible for following corrective and preventive
action of deviation.

8. Other works assigned by line manager

任职资格：

l 工作经验： 3-4
years of experience in Pharmaceutical industry,
QA/QC experience is perferred

l 学历：Bachelor of Science
degree or above, preferably in Pharmacy

l 专业知识：Supervisory and quality assurance experience, Previous experience in
drug product development

l 行业知识：Knowledge of GMP/GLP, regulatory
affairs and Validation

其它知识和技能：Has good communication and organizational skills, is
able to work in an international team environment. Is fluent in English 举报 分享

费森尤斯卡比中国

发展概况

费森尤斯卡比是专注于输液、输血和临床营养治疗领域的全球领导企业，产品覆盖重症及慢性病治疗等多个领域。进入中国以来，费森尤斯卡比始终将“关爱生命”作为不断发展前行的源动力，致力于为中国医护人员提供安全可靠的治疗方案，帮助患者改善生活质量。根植中国三十余载，我们凭借领先的产品和技术、规范化的管理、专业的服务以及研发、生产和营销系统的高效运作，在药品、临床营养、医疗器械等各项业务领域取得骄人业绩，并发展成为中国临床营养、肾病营养治疗和麻醉治疗领域的领导者，跻身中国外资药企十强。

业务领域

费森尤斯卡比在中国的产品种类已覆盖了重症及慢性病治疗等多个领域，包括临床营养治疗、静脉注射药物、慢性病治疗、输液及输血治疗产品及相关医疗器械。

中国印记

目前，费森尤斯卡比在华拥有6个生产中心和3个研发基地。通过一流的本土研发、严密的质量把关和高效的生产流通网络，为医护人员和患者提供及时、值得信赖的医疗解决方案。