Dr. Philip Gravelle

Remedial CSV and process validation prior to FDA inspection in July 2018

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.

Validation of final cleaning including protocols, risk assessment, contact materials database CSV of spreadsheet

Process validation of final cleaning Test Method Validation CSV

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.

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.

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.

X-Ray Crystallography, Bio-inorganic chemistry, organometallic chemistry, 27Al NMR, FTIR