Malektron Solutions Inc is a staffing and recruiting company.
• Participate in Project meetings as the validation representative
• Review project deliverables as applicable
• Act as validation SME during vendor audit
• Generate and execute validation deliverables for SaaS solution
• Develop validation documents including: user requirements, IQ/OQ/PQ, and traceability matrix
• Participate in tracking of testing and creation of summary reports
• Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle.
• Review and approved computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables
• Provide input to testing strategy
• Provide input for change controls
• Significant experience in Quality, Compliance and computer system validation experience
• Prior experience working with offshore teams
• Good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation"