Pam Troxler

Director Qa @SCN BestCo

Charlotte, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2016 — Present

Director Qa @SCN BestCo

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Direct and manage the Quality Assurance functions within the organization. • Interface and coordinate QA activities with Operations, Development, Supply Chain, and Marketing. • Assure that products are produced in compliance with government regulations, company specifications, and customer requirements. • Review and approve validation protocols and reports. • Oversee systems for annual product reviews, consumer complaint responses, investigations, and CAPAs to assure site compliance to standards. • Interface with external third party and customer auditors; manage audit responses and follow up on corrective actions. • Hosted 2023 FDA Inspection resulting in zero observations and no FDA Form 483 issued. • Prepare operating budgets for QA and justify capital expenditures.

SKILLS

Quality System21 Cfr Part 11Verification and Validation (V&V)Analytical ChemistryStandard Operating Procedure (Sop)U.s. Title 21 Cfr Part 11 RegulationV&VQuality ControlGlpFdaCorrective and Preventive Action (Capa)Pharmaceutical IndustryLaboratory Information Management System (Lims)U.s. Food and Drug Administration (Fda)CapaGood Laboratory Practice (Glp)LimsGmpQuality ManagementValidationSopChange Control

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Pam Troxler — Director Qa at SCN BestCo in Charlotte, NC, US | Unifers