QA Supervisor
复星凯特生物科技有限公司
- 公司规模：150-500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：2017-12-07
- 工作地点：上海
- 工作经验：1年经验
- 学历要求：本科
- 职位月薪：0.8-1万/月
- 职位类别：药品生产/质量管理
职位描述
职位描述：
Key Accountabilities:
Key Accountabilities:
1. Documentation: draft QA procedures, review SOPs, control GMP documents and records.
2. QRM: participate in quality risk management, like risk identification, risk assessment, risk control, etc.
3. Qualification, Calibration, and Validation: responsible for calibration of whole facility, responsible for qualification of sterilizer and temperature related equipment, take part in process validation and other method validation.
4. QMS: maintain the quality monitoring system, like deviation management, change control, CAPA, etc., participate in root cause analysis.
5. Product Release and PQR: review the BMR, COA and related deviations before product release, collect information for product quality review.
6. Line QA: patrol in the site, ensure all activities comply with GMP, identify the deviation, in-process release.
7. Other QA functions: responsible for incoming goods inspection and supplier management, take part in self-inspection, assist sampling and environment monitoring.
7. Other QA functions: responsible for incoming goods inspection and supplier management, take part in self-inspection, assist sampling and environment monitoring.
Qualifications:
1. Bachelor's degree or above in biotech, pharma, or relevant.
2. Experience with line QA, validation, and quality audit in pharmaceutical industry, biopharma preferred.
3. Capable of drafting and reviewing SOPs.
4. Strong computer skills including Microsoft Word, Excel, Powerpoint.
5. Knowledge of GMP and relevant regulatory requirements.
6. Key competencies: attention to detail, communication skills, data collection and analysis, problem analysis and solving.
职能类别： 药品生产/质量管理
公司介绍
关于复星凯特生物科技有限公司
复星凯特生物科技有限公司为上海复星医药集团与美国 Kite Pharma（吉利德旗下公司）的合营企业， 2017年 4月于中国上海注册成立。立足于自主研发和技术转移相结合，复星凯特致力于肿瘤免疫细胞治疗技的产业化和规范化，造福中国患者。
About Fosun Kite Biotechnology Co., Ltd.
As a joint venture of Shanghai Fosun Pharmaceutical (Group) Co., Ltd and U.S. Kite Pharma, Fosun Kite Biotechnology Co., Ltd. (hereinafter referred as "Fosun Kite") was established in April 2017 in Shanghai China. Taking a combined approach of internal R&D and external partnering/technology transfer, Fosun Kite is dedicated to the advancement of innovative cell therapy and its industrialization in China to benefit patients.
复星凯特生物科技有限公司为上海复星医药集团与美国 Kite Pharma（吉利德旗下公司）的合营企业， 2017年 4月于中国上海注册成立。立足于自主研发和技术转移相结合，复星凯特致力于肿瘤免疫细胞治疗技的产业化和规范化，造福中国患者。
About Fosun Kite Biotechnology Co., Ltd.
As a joint venture of Shanghai Fosun Pharmaceutical (Group) Co., Ltd and U.S. Kite Pharma, Fosun Kite Biotechnology Co., Ltd. (hereinafter referred as "Fosun Kite") was established in April 2017 in Shanghai China. Taking a combined approach of internal R&D and external partnering/technology transfer, Fosun Kite is dedicated to the advancement of innovative cell therapy and its industrialization in China to benefit patients.
联系方式
- 公司地址：上海市浦东新区盛荣路777号 (邮编：201206)