Preyas Patel
Gmp Qa Operations Consultant at Sarepta Therapeutics
Based in Boston, United States
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Seniority
Other
Department
Other
Location
Boston
Industry
Biotechnology Research
Company size
1.2K
Contact information
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p•••••••@sarepta.com
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Background
About Preyas Patel
I am an experienced Quality Assurance and Quality Control professional with over 10 years of hands-on experience ensuring GMP compliance across the full drug development lifecycle—from early-phase development to commercial manufacturing. My background spans leading biotech and pharmaceutical companies, where I've successfully oversaw CMOs to ensure compliance including batch release, manufacturing, quality control testing and managing key quality systems such as CAPA, deviations, investigations and change control. I’ve played a key role in supporting FDA, EMA inspections and the QP release process for the EU, while also contributing to CMC sections of filings (IND, NDA, IMPD, etc.). With a unique blend of technical QC expertise and strategic QA oversight, I’ve been a valuable asset to cross-functional teams, including manufacturing, regulatory, analytical development, and supply chain. My experience includes managing product quality complaints, reviewing QTAs, leading continuous improvement initiatives, and mentoring teams.
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