Mgr QA in England, United Kingdom

at Amgen

Industry
Biotechnology
Specialization
Medical Devices
Minimum Qualification
Bachelor's Degree
Required Experience
5 - 7 years
Employment Type
Full Time
Gender
Male or Female

Job Description

• Perform raw material and product disposition 
• Authorize lots for shipment 
• Disposition SME for audits 
• Present as Subject Matter Expert in Audits 
• Approve NC investigations and CAPA records 
• Approve change controls 
• Review and approve BMS alarms 
• Designee for QA Management on CCRB. 
• Lead investigations. 
• Lead site audits 
• Own site quality program procedures and process 
• Provide other Quality oversight and support as required.

Requirements

• Doctorate degree & some manufacturing, quality, process development, clinical mfg, engineering experience 
OR 
• Master’s degree & substantial manufacturing, quality, process development, clinical mfg, engineering experience 
OR 
• Bachelor’s degree and substantial manufacturing, quality, process development, clinical mfg, engineering experience AND some managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

Bachelor’s Degree in Life Sciences or related field or the equivalent combination of education and/or experience in related Quality Assurance or Manufacturing experience in the Pharmaceutical or medical device industry.

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