Sejal Patel
Prin. Scientist- QA, a seasoned scientific professional in clinical-pharmaceutical industry with expertise in quality/regulatory/project management. Client liaison, goal orientated, mentor, volunteer. A community leader.
- Role
- Principal Scientist m & Q at Eli Lilly and Company
- Location
- Carmel, IN, US
- LinkedIn followers
- 500 followers
About Sejal Patel
20 years of experience across pharmaceutical/biotech/cro with strong GxP, Regulatory and PMP background. Driven to provide client with strategic solutions for partnerned outcomes. Strong foundation in diverse therapeutic area for Clinical Phase I -IV and preclinical drug development. Effeciently managed operational and quality related communications with cross-functional teams (local and global) and with regulatory authorities (FDA, EU, Swiss medic, ANVISA, MHRA, Health Canada). Experienced on diverse drug presentations such as Tablets, Capsules, Parenteral, Injectables - Suspensions from development-clinical-commercialization. Led simple to complex investigations. Led small to mid size projects and provided leadership oversight on Programs. Performed internal audits. Participated in site audits from clients/regulatory inspection. Planned and implemented proven improvements to gain cost savings. Experienced in CMC related activities and submission in global market, in change management/document management clinical study management (global and local) from start up to close-out. Endorsement for communication, quality, Presenter, client liaison and instrumental trainer-mentor.Education: Bachelors in Science - BiologyAssociates in Information and Technology + 2 yrs of IT lab facultyCertified: PMI - PMP, MS-Sharepoint - Admin/ developer Crash Courses: PPM, Six-sigma
Experience
Principal Scientist m & Q
Jun 2025 — Present · IN, US
Education
South Gujarat University
Bachelor’s Degree, Botany/Biology
1999
NIIT Natinal Institute of Information and Technolgy, Surat India
Professional Diploma, Information Technology
1997 — 1999
Skills
- Standard Operating Procedure (Sop)
- Gmp
- Quality System
- Quality Control
- Validation
- Quality Assurance
- Testing
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