QA Drug Product Operations Manager. QP @ (November 2016 - June 2018)
QA Manager, Quality Systems and Compliance. QP @ (December 2015 - November 2016)
GMP and GDP Inspector @ (April 2014 - November 2015)
Qualified Person @ (November 2012 - December 2013)
Quality (QC and QA) @ (April 2009 - November 2012)
Quality Control @ (August 2004 - June 2008)
Michelle O'Gorman Education
University College Cork
Higher Diploma in Leadership Development
2012-2014
Royal College of Surgeons & IT Sligo
MSc Industrial Pharmaceutical Science
2007-2012
University College Cork
BSc Biochemistry
2000-2004
Michelle O'Gorman Skills
21 CFR Part 11
Analytical Biochemistry
Annual Product Review
Auditing
Batch Records
Batch Release
Biochemistry
Biotechnology
CAPA
Change Control
Change Management
Compliance
Deviation Management
FDA
GLP
GMP
GxP
Performance Metrics
Pharmaceutical Industry
QRM
Quality Assurance
Quality Control
Quality System
Quality System Compliance
Regulatory Filings
Reviews
SOP
Stability
Technology Transfer
Validation
Project Management
Sales
Strategic Planning
Microsoft Office
Management
Training
SQL
Michelle O'Gorman Summary
Michelle O'Gorman, based in Ireland, is currently a Product Quality Lead, Director Quality Operations at Alexion Pharmaceuticals, Inc.. Michelle O'Gorman brings experience from previous roles at Alexion Pharmaceuticals, Inc.. Michelle O'Gorman holds a 2012 - 2014 Higher Diploma in Leadership Development @ University College Cork. With a robust skill set that includes 21 CFR Part 11, Analytical Biochemistry, Annual Product Review, Auditing, Batch Records and more. Michelle O'Gorman has 2 emails and 2 mobile phone numbers on RocketReach.
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