Commissioning and Qualification Engineer
赛诺菲(北京)制药有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-12-08
- 工作地点:北京-大兴区
- 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:1.5-2万/月
- 职位类别:实验室负责人/工程师
职位描述
To ensure the validation & qualification work (equipments / system / computer system etc. ) comply with the global and local requirements.
To provide engineering support mainly in respect of Commission& Qualification of equipment. Support to carry out requalification of the equipment.
KEY ACCOUNTABILITIES
Reponsible for the IQ/OQ/PQ of equipment, schedule the C&Q of equipment aligned with site VMP. (10%) IQ/OQ/PQ,确保设备C&Q与工厂VMP一致。(10%) Draft the C&Q protocol, organize the execution of C&Q activities. (20%) C&Q方案,组织实施C&Q活动。(20%) Confirm and review the protocol from supplier timely to make sure the C&Q activities to meet the project schedule (10%) C&Q活动符合项目进度。(10%) Participate in the new machine installation commissioning and validation. (10%) 10%) Execute the requalification of equipment. (20%) 20%) Maintain & Optimize the C&Q system(10%) C&Q系统。(10%) Termly update C&Q procedure to meet Local&Global requirement. (10%) C&Q程序以符合本地和全球要求。(10%) Termly review the C&Q doc. to meet new requirement from regulatory. (5%) C&Q文档,以适应新的法规要求。(5% Other work from the Head. (5%) 5%)
REQUIREMENTS
Education / Experience
1.Minimum of a Bachelor’s Degree in automation, metrological technology, automation instrumentation or similar disciplines, or equivalent work experience.
2. Specific experience in the areas of equipment and utilites maintenance of is preferred.
3.Minimum of 2 years validation and calibration experience; preferably in Engineering field with an in-depth knowledge of pharmacutical or food industry.
4.Excellent communication skills
5. Sensitive for digital technology
Technical skills &
Competencies / Language
Good manipulative ability, strong sense of responsibility, good teamwork and communication ability, can solve the problem occurred during the work independently.
Skillful Ms office operation
Fluent in English
Behavioural Competencies
(LEAD and others)
1. Efficient communication with different customer
2. Must be conscientious, dedicated and a good team work, open to new knowledge.
1. Efficient communication with different customer
2. Must be conscientious, dedicated and a good team work, open to new knowledge.
职能类别:实验室负责人/工程师
公司介绍
尊重:我们认同和尊重员工、患者和合作伙伴的需求及其多样性。我们承诺在互信的基础上开展透明且具有建设性的沟通。
创新:我们鼓励所有的员工和合作伙伴发挥创业精神、探索创新思路。
信心:我们充满自信,恪守原则。我们一心一意、永不气馁,敢于挑战常规。
齐心:我们对我们的行为、我们的员工、我们的患者和我们生存的环境负责。共同的责任让我们走到一起。
正直:我们承诺,坚持最严格的道德操守和质量标准,决不妥协。
赛诺菲(北京)制药有限公司
赛诺菲(北京)制药有限公司坐落于北京经济技术开发区,占地4万多平方米,现有员工100名左右。公司于2002年12月通过了国家GMP认证,认证范围包括小容量注射剂的分包装,片剂和胶囊的分包装和生产。公司产品于2003年3月开始投放国内市场。
联系方式
- 公司地址:地址:span亦庄经济技术开发区兴盛街7号