George Demian

Quality Operation Specilaist @GSK

Toronto, CA

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Jul 2013 — Present

Quality Operation Specilaist @GSK

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Review, approve and release batch record documentation, Master Batch Documents, Packaging Art Work, Tech. Transfer.etc. Notify the Director of Quality of any issues which may become a compliance issue. In addition Handling Canadian Technical Complaints Process, ensuring that all product quality complaints are being assessed, investigated and reported in compliance with GMP’s, Novartis Quality Manual and regulatory and legislative requirements, also ensuring the initiation of any follow-up activities to ensure that Corrective and Preventative Actions (CAPAs) and Change Controls are tracked and implemented as committed and ensure timely remediation of any related issues

EDUCATION

1985 — 1989

Helwan University Cairo

Bachelor of Applied Science (B.A.Sc.)

2005 — 2007

Seneca College of Applied Arts and Technology

Graduate Certificate

1995 — 1995

University of Toronto

Bachelor of Applied Science (B.A.Sc.) has been accredited by University Of Toronto

1985 — 2011

Helwan University/ Seneca At York

Advanced Post graduate certificate

1996 — 1998

Seneca College of Applied Arts and Technology

Certificate

2009 — 2010

A to Z

PMP Certificate

SKILLS

Corrective and Preventive Action (Capa)21 Cfr Part 11VQuality AssuranceChange ControlRegulatory Affairs• Excellent Knowledge Acquired in Pharmaceutical Quality Assurance & RegulatoryAnalytical ChemistryHigh-Performance Liquid Chromatography (Hplc)Quality ControlGmpPharmaceuticsQuality System• Over 15 Years Progressive Experience in Quality Assurance / Compliance and QuaValidationRegulatory Requirements• Successful Quality Relation Management SkillsBiotechnologyU.s. Food and Drug Administration (Fda)Good Laboratory Practice (Glp)GlpPharmaceutical IndustrySopFda• Review and Approve Batch Record Documentation and Authorize the Release to theCapa• Outstanding Mangement Skills Represented in Organizing the Tasks and WorkloadTechnology TransferStandard Operating Procedure (Sop)Gxp• Manage Canadian Consumer Technical Complaints Process

ABOUT GEORGE DEMIAN

accomplished Quality Operation and Compliance Associate with a strong combination of…

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