Nitesh Sheth Email and Phone Number

About 32 years of experience in Quality Control/ Quality Assurance in leading multinational pharmaceutical industries like J.B Chemical, Cipla and Sun pharma . Currently working with Sun Pharma. Expertise includes Audits and Compliance as per international regulatory standards. Excellent analytical and troubleshooting skills with proven ability in driving numerous quality enhancement, process improvement and cost savings initiatives during the career span.Provide guidance and support to sites on GMP, Product Quality and Compliance requirements.Review and trend internal and external regulatory observations and proactive implementation of best practices and systems to safeguard compliance and business.Review and support for preparing regulatory audit response.Assess cGMP compliance at manufacturing sites through review of QMS w.r.t. following.- Review of monthly quality index and quality matrix data.-Review of Market complaints & Investigations.- Review of Stability failures and impact on product quality.-Out of Specifications & Deviation Investigations for adequacy w.r.t. Root Cause Analysis, CAPAs derived and effectiveness of CAPAs.-Review of Human Errors and providing training to educate personnel on Human Errors .-Review of PV and CV in line with regulatory requirements.Review of Product Quality failures and working with plant Quality, Mfg and R&D for remediation.-Simplification of SOPs with science and logic to facilitate analysts/ operators to do better job enabling easiness and improving quality, compliance and productivity.Specialties: Good analytical knowledge, problem solving skills, exposure on several regulatory audits like USFDA, MHRA, Brazil, Colombia, Russia,Ukraine,Belarus, Peru ,Tanzania,Kenya, Oman, Nigeria, Sudan, Mexico and other International/ national regulatory auditsHave got experience and ability to lead a large team of technically qualified personal.