Padua, Veneto, Italy
Senior QC Chemist experienced in Quality Management, Technical, cGMP, cGALP & Regulatory support (SOPs, protocols, reports, Laboratory deviations-OOT & OOS). Raw Material, Intermediate & Final Product 2PV - sign off and approve in SAP. Experienced in API ICH Stability Studies LT/INT/ACC/Stressed- stability data tracking and review. Stability chamber performance monitored and managed by Spylog software. API Stability Management in LIMS. Assist Laboratory instrument installation and qualification (IQ/OQ/PQ). API OOS/OOT- deviation from specifications root cause analysis & investigation, trending, hypothesis testing in SAP. Follow up of outstanding tasks- scientific approach to closure of outstanding activities. Production planning, resource optimisation, supply chain support, deadlines, training and HSE. Inspection Readiness. Data Integrity- Empower Software Technologies. Empower Software Custom Field calculation of Analytical results. Supported LIMS implementation in the QC department. Adiuto systems user. API analytical control & process optimisation, IPC planning, Analytical Method Validation support, review & approval of lab docs (2PV). Supervise Analytical Instrument Validation and Calibration. Analytical R&D, Process Chemistry, Process Validation & Optimisation, CVP's. Troubleshooting Analytical methods & Instrumentation (HPLC, GC, LC-MS, GC-MS, Waters Empower3-LAC/e). Agilent UHPLC Technology. Malvern 3000 Laser Technology- PSD via Laser & Crystal morfology via Malvern G3 Technology. Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES) Technology for the evaluation of potential metallic impurities resulting from synthetic processes. X-Ray Crystallography of API's. Nuclear Magnetic Resonance (NMR) UltraShield 300. UV/ATR IR/DSC. Lundbeck Italy is Shingo recognised for Op Ex. Specialties: Analytical Method D&V, Chemical Process Control, PSD & Crystal Morphology x formulation, NMR, ICP-OES, Support of Instrument Calibration & Validation, Process Validation & Optimisation. C I & Op Ex.