Diana Soli

Sr Director, Quality Assurance @Palleon Pharmaceuticals

Hallandale Beach, FL, US

EMAILS

d••••@palleonpharma.com

MOBILE NUMBERS

+12•••••••64

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WORK HISTORY

Apr 2022 — Present

Sr Director, Quality Assurance @Palleon Pharmaceuticals

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EDUCATION

1989 — 1992

Southern Connecticut State University

BS, Biology

1985 — 1987

Sacred Heart University

Associates, Biology

2005 — 2007

New York Institute of Technology

MBA, General Studies w Distinction

SKILLS

LimsGxpU.s. Food and Drug Administration (Fda)CtfaMicrobiologyStandard Operating Procedure (Sop)Solid Dose FormulationManagementAsqAsq CqaAsq Senior MemberGcpCapaPharmaceutical IndustrySopFdaProject ManagementCfr 21 Part 11Computer System ValidationExternal AuditQuality AssuranceCorrective and Preventive Action (Capa)Cfr 211ValidationTrackwiseOtcRegulated IndustriesWater Based FormulationsThird Party ManagementRegulationsInternal AuditQuality ControlGmp

ABOUT DIANA SOLI

An experienced Quality Assurance professional with a broad range of expertise.•Over 20 years in the field working in the regulated and non-regulated areas of Pharmaceutical, OTCs, and personal care.•Expertise in CMC oversight, clinical GCP, ISQA Operations,third party/contract manufacturers, computer system validation, GxP auditor, recall coordinator, FDA response room, industrial microbiologist.Proficiency include: auditing (GMP, GCP, 21CFR Part 11, CTF), SDLC and computer system validation, project management

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