Unifers.ai

Marites Marty Orias

Sr Manager, Quality Systems and Compliance @Rigel Pharmaceuticals Inc.

San Jose, CA, US
EMAILS
m•••••@rigel.com
MOBILE NUMBERS
+14•••••••70

Signup · Get unlimited contacts

WORK HISTORY

Mar 2019 — Present

Sr Manager, Quality Systems and Compliance @Rigel Pharmaceuticals Inc.

View department →

EDUCATION

1991 — 1997

San José State University

BS, Chemistry, concentration Biochemistry

SKILLS

ValidationChange ControlManufacturingCMO Quality ManagementIso 17025Quality ControlGmpQuality AssuranceBiotechnologyU.s. Food and Drug Administration (Fda)Technology TransferQuality SystemV&VVerification and Validation (V&V)Six SigmaCorrective and Preventive Action (Capa)21 Cfr Part 11Pharmaceutical IndustrySopFdaIso 13485Quality ManagementAsq Cqa, CqiaVendor Compliance MangementContract Organization ManagementTestingU.s. Title 21 Cfr Part 11 RegulationSoftware DocumentationMedical DevicesCapaIso 9000Standard Operating Procedure (Sop)Biopharmaceuticals

ABOUT MARITES MARTY ORIAS

I am a proven Quality professional with over 20 years experience in Biotech, Hybrid Drug Product Pharmaceuticals, and Medical Device. I have outstanding communication, organizational skills and the ability to handle multiple tasks independently and as a team player. I am experienced in resolving difficult situations under demanding conditions. I have excellent customer service expertise in expediting the release of a product, resolution of deviations, and management of production change control.Expertise includes:• ASQ Certified Quality Auditor • ASQ Certified Quality Improvement Associate• ASQ Certified Quality Engineer (expected Dec 2018)• Product Release and Lot Genealogy Management• Vendor/Supplier Auditing and Management• Project Management• Global cGXP (21CFR, ISO, ICH) • Deviation Resolution and Management• Corrective Action and Preventive Action Resolution and Management• Global Regulatory Inspection • Change Control• Technology Transfer• GXP training• Quality Documentation Systems

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.