SAF Additive Manufacturing

Management of company QMS, including internal audit schedule, complaints, batch release, document control, batch review for imported pharmaceutical and veterinary care products

Acting as Quality Assurance Authorised Approver perform release of medical device products to market (including sterile products).Leading and approving quality investigations for both deviations to standard processes and out of specification product issuesManagement of site quality systems, including writing, update and approval of Site Quality Manuals, Standard Operating Procedures, Local Work Instructions.QA review and approval of process, equipment and test validation protocols and reportsHosting, management and presentation at regulatory (MHRA & BSi), corporate and customer quality audits. Preparation of response to external audit points.Deliverance of site GMP training

Responsible for a large QC laboratory team performing pharmaceutical raw material sampling and testing, bulk pharmaceutical intermediate and packaged product testing for batch release and stability testing for a wide range of solid and liquid dosage forms.

Part of a UK wide team working on the implementation of SAP Enterprise Resource Planning software, with focus on the quality module within the system.Developed and tested processes in SAP, prior to implementation at a large pharmaceutical and medical device manufacturing site.Tracked site wide progress on documentation update (Standard Operating Procedures and local Work Instructions), including authoring of a large amount of new related process documents myself.Assisted with system go live in company plant in France, helping to map out incomplete processes and find solutions during the final stages of project implementation.Delivered site wide SAP system training ahead of project go-live at the Loughborough site, which included both large classroom sessions and smaller 'hands on' training events.Monitored and assessed quality processes on site immediately post 'go-live', acting as first response in the event of 1st time user issues

Responsible for a QC laboratory team performing pharmaceutical raw material sampling and testing (including packaging components), bulk pharmaceutical intermediate and packaged product testing for batch release, stability testing and complaints for a wide range of solid dosage forms (instant and controlled release tablets, instant and controlled release filled capsules, powder sachets).

Responsible for a QC laboratory team performing pharmaceutical raw material sampling and testing, including performing batch review and release, update of specifications (pharmacopeia updates), scheduling of testing resource to meet rapidly changing site demand

Batch release testing of metered dose inhaler products, including assay, fill weight, ethanol content, propellant composition, impurities analysis.

Performed duties as a GLP Study Director for Physico-Chemical Properties studies in support on New Chemicals Notification packages.Work included analytical method development, direction, reporting and approval of phys-chem studies for a global clientele.