Consulting Opportunity – Quality / CSV Expert (Immediate Start)

Company DescriptionM E DORAT CONSULTING provides compliance solutions tailored to support businesses at every stage. With over 25 years of experience in FDA, EU MDR, ISO, and GxP compliance, the company is recognized for its proven expertise and strategic approach to regulatory requirements. Our comprehensive services include gap analysis, risk assessments, certification preparation, and ongoing compliance management. M E DORAT CONSULTING supports businesses globally with a focus on enabling successful market access and maintaining year-round inspection readiness.Role DescriptionWe’re looking for an experienced Quality professional available immediately to support the implementation and validation of an electronic QMS (eQMS) built on a non-pre-validated software platform.This engagement focuses on software validation, risk assessment, and sustainable quality system implementation.Key Areas of Support• eQMS implementation & validation strategy• Assessment/remediation of current CSV and complaint module validation• Software Validation Plan (SVP) review and approval• Assessment of URS and risk assessment • Support for protocol development and OQ/PQ execution• Validation reports, data analysis, and summary reporting• Development of a sustainability plan (change management, revalidation triggers, periodic review, audit trail review, data integrity monitoring)💡 Coding/scripting familiarity is a plus, but not required.📍 Consulting engagement | Immediate availability preferredQualifications✔ Experience in Quality Systems, CSV, and software validation in regulated industries (Life Sciences, MedTech, Pharma, or similar)✔ Proven experience implementing or validating eQMS platforms✔ Strong knowledge of risk-based validation approaches and regulatory expectations (FDA, GxP, etc.)✔ Experience facilitating documentation assessments and validation execution✔ Coding/scripting familiarity is a plus (helpful for system configuration, automation, or data review)If you’re interested—or know someone who might be a strong fit—please send resumes to: medorat@medoratconsult.com #Consulting #QualitySystems #CSV #Validation #eQMS #LifeSciences #MedTech