质量经理Quality Manager
诺化仕制药有限公司WuxiUpdate time: August 9,2019
Job Description
无锡市 惠山区

Objectives:

1. To supervise all quality related activities and to ensure the plant operation is in line with the GMP requirements and the registration files.

2. To be involved in and provided guidance for all quality matters of the site.

3. To review and approve all appropriate quality related documents.


Main missions:

1. To ensure all quality assurance procedures and methods are correctly implemented based on GMP requirements.

2. To ensure all manufacturing activities (including all activities going from purchasing of raw materials, production, control, storage and shipment) are carried out in line with the relevant GMP requirements, and in accordance with the registration files.

3. To manage the staff of the quality department to ensure the efficiency and effectiveness and the smooth cooperation with other departments.

4. HSE and 5S in the area comply with Seqens requirements

5. Other tasks assigned by the superior.


Job Requirements:

1. Bachelor degree of Sciences, Chemistry or other equivalent major (e.g. Microbiology, Pharmacy, Pharmaceutical Sciences, Chemical Engineer, etc.); With knowledge of analytical chemistry.

2. No less than 10 years of work experiences, at least 5-year of senior quality management experience or having worked in a GMP or QA/QC environment, in a pharmaceutical or an active pharmaceutical ingredients plant.

3. Experienced with proven track records in communicating with regulatory officials, hosting regulatory inspections (e.g. EU, NMPA, FDA, Health Canada, etc.), and responding to regulatory requests & observations.

4. Good management and organization skills.

5. Promoting team work sprit and collaboration.

6. Good communication and coordination skills.

7. Continuous Learning.

8. Grasp the P&P, S&P of Seqnes Corporate.

9. Fluent in written, reading and oral in Chinese and English.

10. Skilled in Microsoft Office, Windows etc.


职能类别:质量管理/测试经理(QA/QC经理)

关键字:GMP制药质量经理QCQA

微信

联系方式

上班地址:惠山区广石西路8号


公司信息

诺化仕(无锡)制药有限公司(原罗地亚无锡制药有限公司)为法国Seqens全资子公司,成立于2001年,主要生产原料药物对乙氨基酚的粉末、颗粒及其它医药中间体。

公司位于无锡市广石西路8号,占地面积约4万平方米,建筑面积约1.4万平方米,厂房按GMP要求合理布局,公司是全球多家顶尖的医药公司原料药物对乙氨基酚的粉末,颗粒及其它医药中间体的合作供应商。

公司为员工提供良好的福利,包含但不限于15天年休假、免费班车和工作餐、商业医疗险、传统节假日津贴、年度体检、旅游、年会等;公司也为员工提供良好的职业发展通道和培训机会。

公司网站:www.seqens.com
简历接收邮箱:Wing.Wei@seqens.com

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