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Category : Engineering   |   Location : Bern

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Quality Operation Expert/ Upstream - Life Sciences

Date : 2019-07-26 02:15:08

Déborah Lavabre
deborah@approachpeople.com


Our client, a world leading Biotech company, is currently looking for their future Quality Operation Expert/ Upstream.  
The Quality Operation Expert/ Upstream assures all operations meet cGMP regulations ensuring high level of quality of Cell bank and Bulk Drug Substance.   

Your responsibilities:  

- Support deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).
- Support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.
- Contribute to the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- Revise and approve Standard Operating Procedures as needed. Collect data for metrics and identification of negative trends, support QA SME RA audits, internal audits, inspections.  

Your profile:  

- Masters in Science / Engineering in Life Science or Technical discipline.
- More than 4 years’ experience in a cGMP Bio-Pharma environment of which a minimum of 3 in QA role.
- Good experience of process design and improvement.

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