-
1年经验 -
本科 -
招若干人 -
12-13 发布
- 补充医疗保险
- 五险一金
- 交通补贴
- 餐饮补贴
- 通讯补贴
- 绩效奖金
职位描述
职位描述： 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. 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
联系方式
康南路222号
公司信息
复星凯特生物科技有限公司成立于2017年，是由复星医药的全资子公司上海复星医药产业发展有限公司与Kite Pharma共同设立。Kite Pharma在T细胞免疫治疗领域的研发处于全球领先，而复星医药具有丰富的药品制造与研发经验，并在肿瘤治疗领域拥有多项在研产品。两者这次的联手，将为中国带来全球领先的肿瘤免疫细胞治疗技术。
