Dr. Philip Gravelle
Angestellt, Senior Associate, Maetrics
Llanelli, Vereinigtes Königreich
Werdegang
Berufserfahrung von Philip Gravelle
Bis heute 6 Jahre und 6 Monate, seit Jan. 2018
Senior Associate
Maetrics
Remedial CSV and process validation prior to FDA inspection in July 2018
Bis heute 11 Jahre und 1 Monat, seit Juni 2013
Quality Assurance Manager
Gwalia Life Science Consulting Ltd
Customer-facing Quality & Compliance Manager at IBM Pharmaceuticals and Life Science Division for contract with Astellas Pharmaceuticals, Europe. Computer Systems Validation and qualification of Mainframe computers, servers and data migration and ensuring that all qualification documentation and activities meet regulatory compliance.
1 Jahr und 2 Monate, Nov. 2016 - Dez. 2017
Validation Engineer
Zimmer Biomet
Validation of final cleaning including protocols, risk assessment, contact materials database CSV of spreadsheet
Process validation of final cleaning Test Method Validation CSV
3 Monate, Jan. 2016 - März 2016
Validation Engineer
DePuy Synthes
Validation of Special Processes
Customer-facing Quality & Compliance Manager at IBM Pharmaceuticals and Life Science Division for contract with Astellas Pharmaceuticals, Europe. Computer Systems Validation and qualification of Mainframe computers, servers and data migration and ensuring that all qualification documentation and activities meet regulatory compliance.
9 Monate, Juni 2013 - Feb. 2014
Validation Leader
CooperVision
Validation leader for R & D pilot line for new contact lens product as part of design controls. Responsible for authoring process map, pFMEA & Master Validation Plan, IQ OQ PQ protocols & reports and Quality Plan for project. Validating injection moulding, oven cure, alcohol wash, blister packing, sterilisation, secondary packaging & Deionised Water (DI) plant. Contributed to design outputs conforming to design inputs and validating R & D pilot line for clinical trials.
1 Jahr und 5 Monate, Jan. 2012 - Mai 2013
Validation Engineer
Zimmer Biomet
Validation of process transfer of orthopaedic medical devices. Authored Validation Master Plans, OQ, PQ, FAI, pFMEA documents for Class III medical devices. Optimisation and validation of plasma spray deposited hydroxyapatite (HA) coated process using Taguchi, screening, DoE statistical experiments. Project to be used for Lean-Six Sigma Black Belt certification (DMADV - Design for Six Sigma) Risk assessment of sterilisation processes.
Ausbildung von Philip Gravelle
5 Jahre, Jan. 1991 - Dez. 1995
Inorganic Chemistry
University of North Texas
X-Ray Crystallography, Bio-inorganic chemistry, organometallic chemistry, 27Al NMR, FTIR
Sprachen
Französisch
Fließend
Deutsch
Grundlagen
Italienisch
Grundlagen
Englisch
Muttersprache
Welsh
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