Management of local and global lab equipment projects and new process implementation managing lab equipment lifecycle, supervisioning for equipment third parties activities.Expert for the maintenance and qualification of HPLC, laboratory equipment and computerized system. Support to QC and QA for instrumental issues, new equipment implementation, GOP assessment, equipment investigations.Management of deviation instument related,

AS&T specialist in method development and validation team in the Novartis Center of Excellence.Writing of validation protocols and reports.Skills on Development and validation on HPLC- UV/DAD analyses, LC-MS and its application in forensic analyses, genotoxic impurities analyses, analyses on Sartans, GC / HS-GC-FID tests. Method transfer analyses as receiving site and giving site, writing technical documentation.Experience in DoE and its application in methods development.During this experience I was involved as Author of Testing monographs and technical documentation of analitycal development and validation in all CMC section for Regulatory submission.Deep knowledge of cGxP environment, member in Data Integrity Forum and Quality Culture Team.

Stability analysis on drug products, performing dissolution test, HPLC/UV analyses, GC, TLC.

Quality control Manager, leading a team of 5 people.Writing procedure for the test on finish products, managing recall from the market and mantaining relationship between custumers and suppliers.

Quality control analyst on raw materials and finish products.Research and development on CBE/CBS blends for compound optimization.