Manshi Patel Email & Phone Number

Impactful team leader with 9 years of extensive experience in Pharamceutical industry with strong leadership skills, self-motivated and an innovative scientific thinker, consistently pursuing new challenges to stretch abilities and bring greater return to employers. Responsible for leading the implementation and maintenance of microbiological quality control systems and activities, equipments, procedures and project management and training site staff on aseptic processing microbiology techniques. Established Microbial Identification laboratory and implemented new Genotypic technology. Ensure quality system and Good Laboratories Practices (GLP) compliance and write, review SOPs (Standard Operating Procedure),validation and technical reports. Analyze and interpret microbiological, Environmental Monitoring and analytical testing data and assisted in establishing alert and action limits. Experience using SAP (Systems Application Program).• Provide testing support for the GMP Development Pilot Plants and Release and Stability Tox Phase I/II/III bulk and final fill products. Testing support includes but is not limited to: Environmental Monitoring (air and surfaces), Growth Promotion, Bioburden and Endotoxin (utilities), Biological Indicators, Microbial Identifications, Raw Materials and Fluorescamine (cleaning validation studies), SE-HPLC, A280(UV-Vis), SDS PAGE, Visible Foreign Particulate Matter and Translucent Particle and perform internal audits.• Interacted and worked cross-functionally with Validation, Compliance, Quality Assurance and Pilot Plant Personnel (Manufacturing)• Worked with Quality and Manufacturing to investigate non-conformances, establish root causes and identify and implement corrective and preventive actions

Design, Developed and implemented competency-based job skills training for pharmaceutical operations personnel in compliance with GMP/GLP training programs and FDA regulations.Developed and coordinated programs for the drug development process-Phases I-III.Worked with manufacturing area management and technical experts in the development and validation of competency-based training written modules, instructional materials, quality control and hands-on skills.