Luton, England, United Kingdom
Nimesh Solanki
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FlashIntel GPTNimesh Solanki is an accomplished pharmaceutical professional with over 23 years of experience in drug development, manufacturing, quality control, and regulatory compliance. He has successfully led audits by regulatory bodies such as USFDA and MHRA, implementing robust quality systems and processes to drive performance. Nimesh has a proven track record of executing green and brownfield projects from concept to GMP certification. He is skilled in quality risk management, data integrity, and GMP regulations, with a deep understanding of the pharmaceutical industry's complexities. Nimesh is known for his ability to build and lead high-performing teams and drive business excellence.
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"Accomplished pharmaceutical professional with over 23 years of experience in drug development, manufacturing, quality control, and regulatory compliance. Highly skilled in leading successful audits by regulatory bodies such as USFDA and MHRA, and adept at implementing robust quality systems and processes to drive right-first-time performance. Demonstrated ability to increase productivity and efficiency by up to 200% through better utilization of resources and processes. Proven track record of successfully executing green and brownfield projects from concept to GMP certification. Strong expertise in quality risk management, data integrity, and GMP regulations, with a deep understanding of the pharmaceutical industry's complexities. Adept at building and leading high-performing teams to deliver exceptional results, with a passion for continuous improvement and driving business excellence."Audit exposure:FDA – USA MHRA – UKTGA- AustraliaMCC- South AfricaANVISA - BrazilGCCWHONDA NVISTA
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Nimesh Solanki's Professional Milestones
- Head Quality Assurance (2010-10-01~2016-02-01): Developing and implementing standardized quality control processes to enhance product excellence and customer service.
- Executive Quality Assurance (2005-04-01~2008-08-01): Implementing robust quality control measures to drive exceptional product standards and exceed customer expectations.
Skill
Cleaning Validation
Regulatory Requirements
Sop
Deviations
Validation
Gmp
Quality Management
Calibration
Change Control
Software Documentation
Formulation
Anda
Capa
V&v
Fda
Quality Assurance
Mhra
Quality System
Equipment Qualification
Regulatory Affairs
Glp
Technology Transfer
21 Cfr Part 11
Aseptic Processing
Regulatory Submissions
Good Laboratory Practice
Standard Operating Procedure
U.s. Food And Drug Administration
Corrective And Preventive Action
