Hareet Patel

Provided QA oversight for four CRO/CDMO projects, covering kick-off meetings, technology transfer and GMP manufacturing responsibilities including review and approval of deviations, CAPA, change controls and validation documentation. Reviewed analytical reports, batch records, specifications and validation documents to ensure GMP compliance and data integrity. Closed open CAPAs and managed market complaints, maintaining a clean deviation record throughout the tenure. Achieved zero observations in the ISO

Provided QA oversight for approximately 600 batches per month across three commercial API products (Paracetamol, Domperidone and Domperidone Maleate) spanning the antipyretic and antiemetic ranges. Performed routine shop-floor QA oversight, line clearance verification, in-process checks, and GMP compliance monitoring across manufacturing areas. Raised on-time batch release from 82% to 98% by streamlining batch-record review and introducing a release checklist, and cut batch-record review/release time from

Developed and maintained ISO 9001 and ISO 13485 quality management systems for diagnostic-device manufacturing. Authored and controlled SOPs, quality manuals, validation documents and laboratory records, and handled 2–3 deviations, CAPAs and market complaints per month. Conducted proactive internal audits and plant rounds, supporting internal and external audits in a regulated environment. Delivered compliance and documentation training and contributed to process-improvement and documentation-standardiza

Completed a comprehensive 4-year pharmacy program with a strong foundation in pharmaceutical sciences, including pharmacology, industrial pharmacy, quality assurance, and analytical chemistry. Developed an early interest in regulatory compliance and quality systems, which led to a focused career in