James Young

Senior Associate @Lachman Consultant Services

Philadelphia, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2019 — Present

Senior Associate @Lachman Consultant Services

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EDUCATION

1981 — 1985

Eastern University

BS, Chemistry

N/A

Temple University

Masters of Science Program for Pharmaceutical Quality Assurance/Regulatory Affairs

N/A

Villanova University

Masters of Science Program for Chemistry

SKILLS

VaccinesProgram ManagementSupply Chain ManagementTeam BuildingMedical DevicesCapaSix SigmaGxpQuality AuditingChemistryStrategic PlanningPharmaceuticalsRegulatory RequirementsComplianceLean ManufacturingProcess ExcellenceAuditingTechnology TransferQuality AssuranceQuality SystemQuality SystemsV&VDocument ManagementInspectionDrug DevelopmentBiopharmaceuticalsChange ControlCoachingCleaning ValidationRisk ManagementLimsValidationCross-Functional Team LeadershipPackagingContract ManufacturingGmpPharmaceutical IndustrySopFdaSupplier Management

ABOUT JAMES YOUNG

Innovative and results-orientated cGMP/GDP/GLP Quality/Regulatory Compliance professional with experience in the Bio/Pharmaceutical/Medical Device industries. Progressive and successful history for working in matrix organizations, driving operational excellence/continuous improvements, designing risk management systems, and preparing/hosting BoH inspections. Achievements in driving improvements to Quality Systems, Compliance, and Operational Efficiencies. A proven and enthusiastic leader with \'can do\' attitude, a unique ability for creating ‘To Be’ vision, inspiring personnel to achieve their best, and championing corporate values with management experience in both domestic and international markets. Recognized as a confident decision maker, enterprise leader, and Subject Matter Expert in Quality Systems, manufacturing, packaging, and global logistics/supply chain. A consistent high performer in developing & enhancing Quality Cultures and building/ implementing Best in Class Quality Systems. Extensive experience in: interpreting regulations, designing Quality Management Systems, Policies/SOPs, business integration and technical transfers.

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James Young — Senior Associate at Lachman Consultant Services in Philadelphia, PA, US | Unifers