Involved in testing for leachable substances using HPLCInvolved in testing raw materials and packaging componentsReview and approve batchesPerform HPLC weekly maintenance

-Involved in testing raw materials, in-process and finished goods using HPLC, GCMS and FTIR ·Member of the 5S team. Participated in the initial stages of implementing 5S.·Input in meetings on improvement of Lean for in-process testing·Review solution/balance logbooks when required-Involved in transfer of in process method from parent plant·Part of the lab team that prepared for FDA Audit. Interviewed by auditors on site during live testing·Currently am committed in current role to make sure laboratory is audit ready at all times.·Involved in bi-weekly meetings with QCRI-communicate between the lab and QCRI on incoming raw material issues.·Raise, investigate and complete exceptions and OOS when required. Implement corrective actions and issue awareness memos when necessary.·Train new employees on specific tests and importance of GMP requirements

-Analysis of raw materials and raw, filled and finished product using chemical methods from the Japanese Pharmacopoeia.·Analysis of packaging components (i.e. bottles, nozzles, caps, cartons, inserts)·Perform stability studies for products and packaging components·Write and update new and existing SOP’s and GOP’s·Review batch paperwork, on line packaging inspection and trend Product data·Customer complaint investigation