Nirmal Patel
Associate Director Quality Assurance @Medivant Healthcare
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WORK HISTORY
Associate Director Quality Assurance @Medivant Healthcare
US
Lead end-to-end Quality Management System (QMS) development, governance, and continuous improvement across sterile manufacturing operations.2. Oversee and manage deviations, OOS/OOT investigations, market complaints, ADE investigations, CAPA lifecycle, and change control governance.3. Direct comprehensive validation programs, including equipment qualification, utility qualification, facility qualification, process validation, cleaning validation, and computer system validation (CSV).4. Lead aseptic assurance programs including Aseptic Process Simulation (APS), environmental monitoring support, smoke studies, and development & qualification of VHP cycles for isolators, RABS, and aseptic areas.5. Conduct Quality Management Review (QMR) meetings, quality metrics reporting, and site-level risk assessments.6. Host FDA inspections, regulatory audits, and customer audits; ensure inspection readiness, lead remediation plans, and improve site compliance posture.7. Provide leadership and coaching to QA teams, ensuring effective execution of validation, QMS operations, and continuous improvement initiatives.
EDUCATION
Sikkim Manipal University - Distance Education
Master of Business Administration (MBA), Total Quality Management
SARASWATI INSTITUTE OF PHARMACEUTICAL SCIENCES, CHILODA 242
Bachelor of Pharmacy - BPharm, Pharmacy
ABOUT NIRMAL PATEL
Quality Assurance leader with 14+ years of comprehensive experience in Quality Management Systems (QMS), Validation, Regulatory Compliance, Sterile and non-Sterile Manufacturing, and Inspection Readiness across major pharmaceutical organizations. Proven capability in directing end-to-end validation programs, governing site compliance, managing high-performance teams, and successfully supporting facilities through FDA and global regulatory inspections, including resolution of significant non-compliance issues and prevention/removal of FDA warning letters.
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