Core skills in Corporate Level IT Systems Implementation, Remediation, Compliance, 21CFR Part11, Laboratory IT, SAP ERP, MS Dynamics, ITSM, Aris Global, IT QA, QA, QC, Technical Support & Data Integrity

Corporate level IT / CSV solutions:

• IT Service Management (ITSM, HPSM) / ServiceNow,

• Data Migration

• Legal Hold / Enterprise Vault & PST Migration

• Active Directory &, Privileged Identity Management

• SAP / ERP

• Remediation

• Data Integrity

Automation:

• Emerson DeltaV, Syncade, OsiSoft PI & Infobatch documentation

• Lighthouse Environmental Monitoring System

Laboratory:

• Method Development

• HPLC, UV, FTIR, Moisture, Wet Chemisty etc

Other skills: FDA 483, Management & coordination of Quality, Testing, Validation, Compliance and Commissioning activities in Pharmaceuticals & Biotechnology Industries.

Full validation lifecycle activities with efficient project and test planning, providing satisfactory reports. GxP, GAMP5, including VMP, IQ, OQ, PQ, DQ, RA, IA, FRS, URS, VS, RTM/TM, Use cases, Gap analysis, Root Cause, Deviations, Defects / Non Conformances, SOP's, CAPA's, ERES,

Compliant to FDA and MHRA regulatory bodies

Education

Bachelor Of Science (Hons) Biotechnology

University Abertay, Dundee Scotland 1993

Past Clients

Novo Nordisk, Denmark

Leo, Denmark

Biogen, Denmark

Hollister, Denmark

Pronova, Denmark

Merck, Germany

MSD, Germany

Teva, Hungary

Zoetis, Belgium

Johnson & Johnson, Netherlands

Friesland Campina, Netherlands

Hoffman La Roche, Switzerland

GlaxoSmithKline, United Kingdom

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