About Malektron Solutions Inc

Malektron Solutions Inc is a staffing and recruiting company.

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Validation Specialist← All Jobs

2015-10-02 | Foster City, CA | $55/ hr on C2C | 6+ Months Contract


"Job Description:
• 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""


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