Peter Gavin Email & Phone Number

Pfizer Newbridge

Activities relating to the introduction of new equipment on site, including writing URS’s, FS’s & RTMs.Generation and execution of IOQ’s for new equipment.Generation and execution of Test Documents for modifications to existing validated equipment and utilities. Review of welding documentation and walking down of P&ID’s following modifications to utility systems.

Performing all Validation activities relating to the Analytical Equipment, writing URS’s, writing/ reviewing & approving IQ, OQ & PQ documents as well as performing PQ’s where necessary.Ownership of all Change Control and Deviations associated with the Analytical Equipment. Completion of such in a timely and efficient manner.Introduction & Validation of new equipment in the Analytical Lab, including generation and progression of change controls, writing technical documents & procedures and the training of relevant personnel.Maintaining the Laboratory equipment and all relevant procedures and documentation to auditable standards.

Citywest, Dublin

Performing dissolution testing on both in-process and finished products, sample preparation and analysis by both HPLC and UV.Performing assay and degradation testing on both in-process and finished products, sample preparation and analysis by HPLC & GC.Solid state characterisation of API drug substances using DSC, TGA, Microscopy & PSA.