2002 -2003 manufacturing and packaging team member @
1998 -1999 manufacturing and packaging team member @
Claire James Education
Sligo
Black belt (Six sigma)
2015
Institute of Technology, Sligo
Business (Operations Management and Supervision)
2012-2014
Waterford Institute of Technology
Bachelor of Applied Science - BASc (Engineering Science)
1999-2002
Claire James Skills
Biotechnology
Validation
GMP
CAPA
FDA
Sop
21 CFR Part 11
Change Control
Biopharmaceuticals
Pharmaceutical Industry
GLP
LIMS
Quality System
Technology Transfer
Quality Assurance
Manufacturing
Continuous Improvement
Management
Lean Manufacturing
Aseptic Processing
Packaging
Java
Microsoft Excel
Corrective and Preventive Action Capa
Standard Operating Procedure Sop
Corrective and Preventive Action
Standard Operating Procedure
Claire James Summary
Claire James, based in Waterford, IE, is currently a Director drug product division, Quality Strategy and Performance at Thermo Fisher Scientific. Claire James brings experience from previous roles at Thermo Fisher Scientific, Haleon, EirGen Pharma and Sanofi Genzyme. Claire James holds a Black belt in Six sigma @ Sligo. With a robust skill set that includes Biotechnology, Validation, GMP, CAPA, FDA and more. Claire James has 2 emails on RocketReach.
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