Shefali Patel
Sr. Scientist; QC/QA/GMP Specialist
- Role
- Qa Operations at Boehringer Ingelheim
- Location
- Fremont, CA, US
- LinkedIn followers
- 500 followers
About Shefali Patel
Experienced specialist in Biotechnology /Pharmaceutical Industry:• Effective collaborator with Quality Control/Quality assurance, Manufacturing, SQM, Process Development and Research.• Managing stability program for commercial products• Strong cGMP skills in Quality Data Analyses (Product release/stability trending, Analytical development) and documentation (authoring and reviewing SOPs, Technical Registration Documents (TRD), Technical assessment reports, Stability Protocol/ Reports; Drug Specification/CofA, OOS/OOT investigation, Root cause analysis/non-conformance; CAPA and Change Control, Risk assessment) • Conducting and supporting Compliance Inspections and Audits/Quality Matrices • Project management with CTL/CRO/CMO for Analytical Method Development, Assay Qualification / Validation, Technology Transfer and Drug stability program• Hands-on / trouble shooting expertise in Assay Development for Microbiology/Immunology, Virology, and Drug Stability• Strong problem solving and communication skills with effective verbal and writing ability• Highly motivated specialist, quick and eager learner, skilled team member as well as independent contributor with supervisory experience.• Review / Release commercial product batch records
Experience
Qa Operations
Sep 2024 — Present · Fremont, CA, US
Education
The Maharaja Sayajirao University of Baroda
MS
The Maharaja Sayajirao University of Baroda
BS
University of California, Santa Cruz
Project and Program Management
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