Bernadette O'Brien Email & Phone Number
Director @ Quartz Quality Limited
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Bernadette O'Brien Location
- Waterford, IE
Bernadette O'Brien Work
- 2017 -now Director @
- 2017 -now Senior Consultant and Qualified Person @
- 2014 -2017 Head of Quality @
- 2012 -2014 Site QA Manager @
- 2012 -2012 QA Manager Fill Finish Expanded Operations @
- 2011 -2012 QA Manager Fill Finish Capacity Expansion @ Genzyme Ireland, a Sanofi Company
- 2009 -2011 QA Manager Fill Finish @
- 2006 -2009 Quality Services Manager @
- 2000 -2006 Quality Compliance Manager and QA Manager @
- 1996 -2000 Quality Manager @ Medentech
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 3 emails on RocketReach.
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