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Claire James Location
Waterford, IE
Claire James Work
Director drug product division, Quality Strategy and Performance @ (January 2026 - Present)
Director, EU GMP and Regulatory Compliance EU and APAC @ (April 2025 - February 2026)
Director of Quality @ (July 2022 - April 2025)
Director of Quality @ (April 2021 - July 2022)
Senior Quality Systems and Compliance Manager @ (January 2018 - April 2021)
Snr Compliance Manager @ (November 2016 - January 2018)
Quality Systems Manager @ (May 2016 - November 2016)
Quality Systems and Compliance global Lead (Site and new platform Combination Drug Products) @ (January 2016 - May 2016)
Quality improvements project lead @ (January 2014 - December 2015)
Quality Management System Champion @ (March 2011 - January 2014)
Quality Assurance Team Leader @ (April 2008 - March 2011)
Quality Assurance specialist (Quality Systems, Steriles and Oral Dose) @ (October 2003 - January 2007)
manufacturing and packaging team member @ (September 2002 - October 2003)
manufacturing and packaging team member @ (February 1998 - September 1999)
Claire James Education
Institute of Technology, Sligo
Business (Operations Management and Supervision)
2012-2014
Waterford Institute of Technology
Bachelor of Applied Science - BASc (Engineering Science)
1999-2002
Sligo
Black belt (Six sigma)
2015
Claire James Skills
21 CFR Part 11
Aseptic Processing
Biopharmaceuticals
Biotechnology
CAPA
Change Control
Communications Strategy
Continuous Improvement
Corrective and Preventive Action (CAPA)
Culture Change
FDA
GLP
GMP
LIMS
Lean Manufacturing
Management
Manufacturing
Pharmaceutical Industry
Project Management
Quality Assurance
Quality Control
Quality System
SOP
Standard Operating Procedure (SOP)
Technology Transfer
U.S. Food and Drug Administration (FDA)
Validation
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 2012 - 2014 Business in Operations Management and Supervision @ Institute of Technology, Sligo. With a robust skill set that includes 21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA and more. Claire James has 2 emails and 1 mobile phone numbers on RocketReach.
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