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Bernadette O'Brien Location
Waterford, IE
Bernadette O'Brien Work
Director @ (February 2017 - Present)
Senior Consultant and Qualified Person @ (February 2017 - Present)
Head of Quality @ (November 2014 - January 2017)
Site QA Manager @ (December 2012 - October 2014)
QA Manager Fill Finish Expanded Operations @ (May 2012 - November 2012)
QA Manager Fill Finish Capacity Expansion @ Genzyme Ireland, a Sanofi Company (March 2011 - June 2012)
QA Manager Fill Finish @ (April 2009 - September 2011)
Quality Services Manager @ (October 2006 - April 2009)
Quality Compliance Manager and QA Manager @ (July 2000 - September 2006)
Quality Manager @ Medentech (December 1996 - June 2000)
Bernadette O'Brien Education
waterford institute of technology
Masters (Business Administration)
2006-2008
Trinity College Dublin
Post Grad Diploma (Pharmaceutical Technology (Qualified Person))
2002-2003
University College Dublin
BSc (Pharmacology)
1992-1996
Bernadette O'Brien Skills
Quality Risk Management
Quality System Design
GMP
Integrated Process Control Strategy
Sterile Manufacturing
Regulatory Audits
Quality Systems Design
Risk Management
Sterilization
Validation
Quality Auditing
CAPA
Change Control
GxP
Aseptic Processing
Technology Transfer
Quality System
FDA
Quality Assurance
Biotechnology
Quality Strategy
U.S. Food and Drug Administration (FDA)
Pharmaceutical Industry
Corrective and Preventive Action (CAPA)
Standard Operating Procedure (SOP)
Customer Service
Good Distribution Practice Gdp
Corrective and Preventive Action Capa
Standard Operating Procedure Sop
Manufacturing
Business Analysis
Biopharmaceuticals
Pharmaceutics
Data Integrity
Quality Control
Good Laboratory Practice Glp
Marketing
Project Management
V&V
Medical Devices
Strategic Planning
u.s. Food and Drug Administration Fda
Auditing
u.s. Food and Drug Administration
Corrective and Preventive Action
Standard Operating Procedure
Good Laboratory Practice
Good Distribution Practice
Bernadette O'Brien Summary
Bernadette O'Brien, based in Waterford, IE, is currently a Director at Quartz Quality Limited. Bernadette O'Brien brings experience from previous roles at The Compliance Group and Sanofi. Bernadette O'Brien holds a 2006 - 2008 Masters in Business Administration @ waterford institute of technology. With a robust skill set that includes Quality Risk Management, Quality System Design, GMP, Integrated Process Control Strategy, Sterile Manufacturing and more. Bernadette O'Brien has 5 emails and 2 mobile phone numbers on RocketReach.
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