mayur patel

director quality assurance

About

* A scientific professional with 20 years of diversified experience in Quality Management with a major pharmaceutical company. * Certified Green Belt with experience in implementing improvement projects within Quality Management. * Broad knowledge base of cGMP, analytical skills and quality systems. Strong communication skills, strategic thinking and planning, result oriented with good organizational skills. * Expertise in scientific research report writing, Method Validation, method transfer and Computer Systems Validation (CSV) protocol. *

Country

united states

City

new york

Industry

pharmaceuticals

Skill

validation, gmp, quality system, fda, change control, quality assurance, quality management, cleaning validation, glp, lims, v&v, chromatography, hplc, computer system validation, six sigma, software documentation, sop

Experience

senior specialist, regulatory affairs-cmc

merck

2011-5 - 2018-2 · 6 yrs 10 mos

director quality assurance

rucdr infinite biologics

2018-2 - Present · 8 yrs 8 mos

scientist

roche

1991-2 - 1996-8 · 5 yrs 7 mos

senior scientist

roche

1996-8 - 2010-9 · 14 yrs 2 mos

Successfully improved and streamlined several projects using Lean Six Sigma methodologies resulting in significant reduction in cycle-time, errors and increased productivity and data reliability. Evaluated internal groups for compliance, prepared action plans and implement changes. Performed impact analysis and troubleshot changes. Set Key Performance Indicators (KPI) and performed gap analysis. Analyzed performance of quality systems, provided metrics, measures and results in order to determine effectiveness of the systems and improvements. Provided support training of quality systems requirements within and outside of the department for increased awareness of changes. Scheduled and performed internal quality audits to assure compliance to cGMP. Designed, implemented and tracked corrective and preventive measures.