Helen Gray

R & d Manager - Quality Ena @Reckitt

Kingston upon Hull, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Apr 2016 — Present

R & d Manager - Quality Ena @Reckitt

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Ensures the Global R&D quality management system supports New Product Development and is fit for purpose. Leads a team responsible for QA oversight and the operation of the Quality Management systems in the US and Europe. Ensures that Investigational Medicinal Products (IMPs) are manufactured and released to cGMP and in compliance with clinical trial applications and regulatory directives. QA/QP support for cross-functional teams throughout the product development process.

EDUCATION

2006 — 2009

University of Brighton

MSc, Industrial Pharmaceutical Studies (QP)

1994 — 1998

Sheffield Hallam University

BSc (Hons), Biomedical Chemistry

SKILLS

MicrobiologyManufacturingRegulatory AffairsLifesciencesQuality AssuranceChange ControlFormulationBiotechnologyLife SciencesRegulatory RequirementsGxpQuality AuditingPharmaceuticsAnalytical ChemistryPharmaceutical IndustrySopFdaValidation21 Cfr Part 11Continuous ImprovementCapaGmpTechnology TransferClinical TrialsQuality SystemV&VGlpR&D

ABOUT HELEN GRAY

I am a successful quality assurance manager, eligible to act as a Qualified Person via…

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Helen Gray — R & d Manager - Quality Ena at Reckitt in Kingston upon Hull, GB | Unifers