Description
Summary of Qualifications Highly qualified licensed chemist with experience in Oral Solid Dosage, Parenterals Manufacturing in Quality Control Laboratory, Quality Assurance, Quality System, Quality Operations Technology Transfer and Process Scientist in Technical Services areas. Solid background in analytical methods development and process validation, analytical method transfers and cleaning validation activities. Strong knowledge in quality systems (as Labware and Empower validation and system administrator, change control system administrator and quality review and annual product review specialist), pharmaceutical technology processes. Subject matter expert in chromatography (HLPC), Spectroscopy (NIR, FTIR), Quality Systems (APR, Change Control, SAP, LIMS and Empower). Ample exposure and experience with FDA, EMEA and Corporate inspections. Excellent leadership and teamwork skills with experience in lean laboratory concepts to improve productivity and efficiencies. Flexible Integrated Technical Services (FITS) in Merck
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