Lorice Ekereke

Site Quality Operations Leader at Pfizer

Based in San Marcos, United States

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Seniority

Manager

Department

Operations

Location

San Marcos

Industry

Pharmaceutical Manufacturing

Company size

107K

Contact information

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Email

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l•••••••@pfizer.com

Phone

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Background

About Lorice Ekereke

Accomplished engineering manager with 16+ years of progressive experience in medical with focus in product quality, reliability, and supplier quality. My experience spans from product development to post market with product transfer to high volume facilities and Contact Manufacturers (CM). Specialties: Medical Devices Class I, II and (Implantable, Single use and Capital Equipment), Design Controls, Design of Experiment, Process Characterization, Qualification and Validation, Test Method Validation, Design Verification, Process Capability, Control Plans, Manufacturing Line Setup, DRM (Design for Reliability and Manufacturability), Submission to Regulatory Agencies, Lean Sigma, Software Lifecycle/Validation, CAPA, Root Cause Analysis, Remediation, Risk Management, Health Hazard Analysis, Auditing, DFMEA, PFMEA and PPM. Knowledgeable of the following standards: 21 CFR 820, ISO 13485, ISO 14971, ISO 11318, EN 45502-2-2, ISO 5841-3, EN 60601-1, EN 60601-2-2, IEC 62304 and many more.

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