- 工作地点：上海
- 职位：QA Specialist 质量保证专员
- 信息来源：前程无忧(51JOB)
说明：
公司官网:ww***com[点击查看]
职能类别:药品生产/质量管理
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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. Line QA: patrol in the site, ensure all activities comply with GMP, identify the deviation, in-process release, materials release. Has regular contact with the QC/Production/ Facility/Equipment/Ware house/Shipping’s teams.
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. Other QA functions: responsible for incoming goods inspection and supplier management, take part in self-inspection, assist sampling and environment monitoring.
任职要求：
1. Bachelor’s degree or above in biotech, pharma, or relevant.
2. Experience with line QA, 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.
公司简要介绍：
公司名称:Kite Pharma
公司类型:上市公司
公司介绍:"To bring about this transformation, we're developing innovative products that harness a patient's own immune system to target and attack cancer cells. In just three years, our singular focus and strategic collaborations, including multiple Cooperative Research and Development Agreements with the National Cancer Institute, have enabled us to advance an industry-leading pipeline of chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates to address both hematological (blood-based) and solid cancers.
On October 3, 2017, Kite became a Gilead company with the completion of the acquisition by Gilead Sciences.
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