QA Specialist / Manager
礼来中国ShanghaiUpdate time: May 6,2019
Job Description
Key Objectives/Deliverables:
- CMO governance:
- Performs quality visits at contract manufacturers to provide quality oversight, such as changes & deviation handling, manufacturing instruction reviewing etc
- Perform site batch release for Elanco contract manufacturing products
- Prepare and maintain the quality agreements
- Provide quality leadership on the manufacturing floor
- Support production floor operations in validation activities
- Ensure deviations, out-of-specification or out-of-trend data are investigated adequately
- Facilitate periodic audits/inspections of production areas and ensure the audit outcomes are responded adequately
- Investigate customer complaints
- Support annual product reviews
- Assist Quality team Leader of EEM China to maintain Quality System of EEM China
- External suppliers governance
- Performs quality visits at external suppliers to provide quality oversight, review changes, participate in complaint investigations, and other important quality activities
- Prepare and maintain the quality agreements
- Perform supplier governance with risk based approach that also is compliant with recognized industry quality standards such as ICH, ISO etc
- Ensure changes in suppliers are well communicated and assessed
- Review investigation on the out-of-specification or out-of-trend data
- Facilitate periodic audits/inspections of production areas and ensure the audit outcomes are responded adequately
- Investigate customer complaints
- Maintain global supplier management network for EEM China
基本资格要求
Minimum Requirements:
- Three years above of experience in drugs/APIs/vaccines QA, technical or production
- Ability to work independently
- Capable of speaking, writing, and reading English fluently
Additional Preferences:
Demonstrated knowledge of cGMPs, quality systems and pharmaceutical supply chain.
Good understanding of industry standards such as Pharmacopeia, ISO standards, etc.
Demonstrated knowledge of cGMPs, quality systems and pharmaceutical supply chain.
Good understanding of industry standards such as Pharmacopeia, ISO standards, etc.
Education Requirements:
Bachelor’s degree or above, majored in pharmaceuticals, biochemistry or related science
Bachelor’s degree or above, majored in pharmaceuticals, biochemistry or related science
Other Information:
Frequent travel, approximately 2 weeks/month
Frequent travel, approximately 2 weeks/month
地区
亚洲/太平洋地区
国家
中国
城市
上海
职位过期
2019-07-31
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