Looking for Validation Consultant or Engineer @ Naperville,IL

Greetings,

Please see the below requirement and send me the best profiles ASAP.

Role : Validation Consultant  or Engineer

Location : Naperville,IL

Duration : 4 Months

Validation experience: in SAP environment 6-10 years.

SAP Experience: 4-6 years.

• Extensive experience in Computer System Validations (CSV) ensuring legislative compliance in GxP environment for many critical modules/systems.
• Develop, implement and manage a comprehensive ITQ deliverables (URS, FS, DS, Test Plan, Test Report, Traceability Matrix, SOPs. Experience in writing SOPs, validation protocols.
• Work with internal/external teams.
• Coordinate validation efforts within the Quality System Regulation (21 CFR Part 820), Electronic Records; Electronic Signatures (21 CFR Part 11)
• Extensive experience on 21CFRPart 11, 820 compliance on critical projects.
• Experience in preparing, enacting, enforcing across different teams and ensuring deliverables completion conforming to various FDA regulations.
• Oversee experience to ensure adherence to IT policies, procedures and industry standards and best practices, IT Guiding Principles.
• Good communication skills (verbal and writing), Team Management skills.

Regards,

Bhagya Dutta

Bhagya.dutta@pamten.com

PamTen Inc | www.pamten.com

“Creative Technology Services That Make A Difference”

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