Simon Wynne
Senior QA Auditor at ERT- Claim this Profile
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Bio
Experience
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ERT
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior QA Auditor
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Apr 2019 - Present
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Juniper Pharma Services
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Nottingham, United Kingdom
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Lead Quality Officer
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Oct 2013 - Apr 2019
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Catalent Pharma Solutions
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Lead Quality Officer
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Oct 2013 - Apr 2019
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Merck Animal Health
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Milton Keynes, United Kingdom
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Senior QA Officer
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Nov 2009 - Oct 2013
Position within the QA group for a company that manufactures injectable and orally delivered vaccines. The main role responsibilities were pharmaceutical quality system management, supplier management, external and internal auditing and continuous improvement. Position within the QA group for a company that manufactures injectable and orally delivered vaccines. The main role responsibilities were pharmaceutical quality system management, supplier management, external and internal auditing and continuous improvement.
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Hospira
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Product Safety Officer
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Sep 2008 - Sep 2009
Position within the Pharmacovigilance section dealing with adverse events and complaints for the company’s range of generic pharmaceutical and medical devices. Interaction and response preparation for with regulatory agencies, typically MHRA and IMB. Position within the Pharmacovigilance section dealing with adverse events and complaints for the company’s range of generic pharmaceutical and medical devices. Interaction and response preparation for with regulatory agencies, typically MHRA and IMB.
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SAFC BIOSCIENCES (SIGMA-ALDRICH), ANDOVER
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Andover, Hampshire
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QA and QC Manager
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Sep 2004 - Jul 2007
Accountable for site compliance to ISO9001:2000 and cGMP in line with EU and US requirements and for release of batches manufactured at UK and US sites into the European markets. Accountable for site compliance to ISO9001:2000 and cGMP in line with EU and US requirements and for release of batches manufactured at UK and US sites into the European markets.
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Avecia
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Northwich, Cheshire
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Project Team Leader
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Oct 1989 - Dec 2003
Accountability and responsibility for delivery of project goals and budget management concerning the manufacture of API’s. Accountable for manufacturing and development laboratories. Line management of a process development group and environmental monitoring program. Accountability and responsibility for delivery of project goals and budget management concerning the manufacture of API’s. Accountable for manufacturing and development laboratories. Line management of a process development group and environmental monitoring program.
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Education
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Henry Fanshawe