Leiden, Provincie Zuid-Holland, Netherlands
QA and Regulatory Consultant Senior Janssen Biologics B.V.
Biotechnology
Education
University College Cork 1994 — 1996
Master's Degree, Food Science and Technology
University College Cork 1990 — 1994
Bachelor's Degree, BSc Hons
FAS Cork Training Centre (Bishopstown)
•Quality Assurance / Quality Control Certificate Parts 1 & 2, City & Guilds Cork, 1998
Experience
Janssen Biologics BV Leiden, The Netherlands January 2015 - Present
BioMarin Pharmaceutical Cork, Ireland September 2014 - December 2014
Teva Pharmachemie Haarlem, The Netherlands April 2014 - September 2014
Crucell Leiden, The Netherlands October 2013 - March 2014
Janssen Biologics, Ringaskiddy Cork Ireland May 2013 - September 2013
GlaxoSmithKline Biological Wavre Belgium December 2012 - May 2013
Crucell Leiden The Netherlands February 2012 - November 2012
Omrix Rehovot Israel October 2010 - February 2012
Cordis Cashel Ireland January 2010 - October 2010
Boston Scientific Galway Ireland November 2008 - December 2009
Skills
Software Documentation, Regulatory Submissions, Cleaning Validation, 21 CFR Part 11, GxP, Quality Management, Quality Control, SOP, Quality Auditing, Reviews, Deviations, Vaccines, LIMS, Equipment Qualification, Technology Transfer, Regulatory Affairs, FDA, Pharmaceutical Industry, Factory Acceptance..., Root Cause Analysis, Acceptance Testing, Aseptic Processing, Change Management, Medical Devices, Computer System..., FMEA, Regulatory Requirements, Lean Manufacturing, GAMP, Quality System, Commissioning, FDA GMP, ISO 13485, Sop, ISO, Validation, Biotechnology, GLP, Biopharmaceuticals, Iso 9000, CAPA, Heavy Equipment, GMP, Analytical Chemistry, Quality Assurance, V&V, HPLC, Calibration, Change Control