Job Reference: J5634064
Updated On: 30/11/2020
Status: Now Interviewing
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Role OverviewI'm currently recruiting for a Quality Specialist from a Sterile or Biologics background to join a leading Contract Manufacturing organisation.
This is a brand new position created to support growth across the business and is an exciting time to join!
Key Duties and Responsibilities1. Conduct and review technical deviations and incident investigations; providing a detailed summary report of your findings.
2. Analyse and assess incident impact against the sterile medicine GMP regulations.
3. Collect data, lead and perform Root Cause Analysis of findings in order to provide effective corrective and preventative actions (CAPA’s).
4. Present technical status updates to the Management team as well as rain and coach operational personnel to develop their technical writing and investigation skills.
Role RequirementsTo be successful in your application to this exciting opportunity as a Quality Specialist, you must have the following:
1. Experienced working as a Quality Investigator within Sterile or Biologics environments.
2. Experience of cell culture methods would be desirable
3. A working knowledge and practical experience of GMP Regulations, ideally within Aseptic processing.
Key Words: Quality Investigator, Sterile, Biologics, CAPA, GMP
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