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.