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GMDP-0025

Senior Quality Assurance Specialist

On Assignment
12
Years Experience
GMP & GDP
Specialization
United States
Location
About This Expert

Highly accomplished Quality Assurance Leader with over a decade of experience driving compliance, risk management, and continuous improvement across highly regulated laboratory, pharmaceutical, and clinical environments. Proven expert in directing global CAPA program strategies, executing complex root-cause analyses, and maintaining rigorous audit readiness for regulatory bodies. A collaborative leader adept at bridging cross-functional gaps between Clinical, Laboratory, and IT teams to safeguard data integrity and enhance systemic performance

Competencies

Expert
CAPA Management SOP Writing & Review Deviation Management
Advanced
Batch Release Change Control Annual Product Quality Review Supplier Auditing Equipment qualification GMP Auditing Deviation Management Out-of-Specification (OOS) Investigation Regulatory inspection support Data Integrity Internal auditing
Intermediate
Process validation Computer system validation Regulatory Submissions
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