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GMDP-0025

Senior Quality Assurance Specialist

Available
12
Years Experience
Quality Assurance
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
Request Information

Interested in this expert? Fill in the form below to start the process. For €50, you'll receive a detailed anonymized CV. If you'd like to proceed to a personal introduction, that's €1000.