Nimishkumar Patel Email & Phone Number

Proven Quality Operations Leader in regulated pharmaceutical industries, boasting over 24 years of experience.• Offering solution-oriented and strategic expertise, backed by extensive leadership and hands-on experience in quality, operations, and project management within the pharmaceutical industry.• Skilled in overseeing large and complex operations, including the development, integration, and implementation of systems, processes, and facilities.• Armed with a comprehensive understanding of quality assurance programs, and adept at overseeing compliance and data integrity, with a successful track record of boosting organizational revenues through effective operation management.• Demonstrating excellent analytical thinking abilities and a keen attention to detail in ensuring systemic quality.• Articulate in both written and verbal communication, with strong interpersonal skills, having collaborated across various organizational levels to meet unique departmental requirements.• Providing QC support for ANDA and Dossier filings with US FDA and EU regulatory agencies.• Proficient in Quality Management System for tracking and execution of timely closure of OOS/OOT investigations, deviations, product complaints, change controls, and CAPA.• Conducting vendor audits, lab audits, qualifying external facilities, and working with multiple CMOs and brand companies to gain insight into different quality and compliance standards and expectations.• Skilled in record-keeping, documentation practices, and training.• Possessing extensive knowledge of cGMP, ICH, 21 CFR Part 11, 210, 211, 820, and 600 guidelines.• Extensive hands-on experience in starting and expanding QC labs, managing metrology operations, and employing project management skills for new product launches, with a thinking-outside-the-box attitude to overcome unique challenges.• Successfully brought the Six Sigma approach to quality systems improvement by analyzing current processes, performing gap analysis, and designing and implementing improvement plans.