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Charles McNulty
Sr. Validation & Quality Engineer

CQV Facility, Utility, Cleaning, Process Validation & Compliance Expert

Professional Overview:
Boasting over 20 years as an ASCP Board Certified Medical Technologist, I possess extensive industry expertise specializing in Validation and Quality Systems across diverse sectors including Biopharmaceuticals, Clinical Laboratory Sciences, Cosmetics, Medical Devices, Nutraceuticals, and Pharmaceuticals.

Key Proficiencies:
My experience encompasses pivotal roles as a Project Lead and Team Contributor, specializing in Gap Analyses, Risk Assessments, Compliance Audits, and Commissioning (ICQ/CQV). I have a proven track record in developing and implementing Validation Master Plans, as well as overseeing Facility, Utility, and Equipment Qualification (IQ/OQ/PQ). Additionally, I excel in Cleaning Validation, Process Validation, and implementing Continuous Improvement methodologies alongside Lean Six Sigma applications.

Core Competencies:

Validation and Quality Systems: Adept in devising and executing comprehensive Validation and Quality Systems across multiple industries.

Project Leadership: Demonstrate strong leadership capabilities as a Project Lead, guiding teams toward successful project outcomes.

Analytical Skills: Proficient in conducting Gap Analyses and Risk Assessments, ensuring compliance and mitigating risks effectively.

Continuous Improvement: Championing the implementation of Continuous Improvement methodologies and Lean Six Sigma applications to optimize processes..

Professional Commitment:
Driven by a commitment to excellence, I bring a wealth of experience and a broad skill set honed across various industries, facilitating the achievement of stringent quality standards and regulatory compliance.

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