Please send resume on *kum...@selectsourceintl.com*
<kum...@selectsourceintl.com>



Job Title          :           Validation Engineer

Location          :           Northridge, CA

Duration          :           6 Months


*Principal Duties & Responsibilities:  *• Contributing to the development
of Requirements, Specifications, and Validation documents
• Developing Test scripts based on Software, Hardware and System level
requirements
• Developing and executing Design Verification and Validation protocols and
reports for Software, Hardware, and Integrated Systems
• Writing verification and validation reports
• Authoring, reviewing and approving validation documents developed by the
Product Reporting Department, ensuring the documentation meets regulatory
requirements and quality standards.
• Initiating Risk Assessments on current systems.


*Job Demands:  *This job requires the Quality Assurance and Validation
Specialist to have the ability to handle multiple projects and execute in a
timely manner. The Quality Assurance and Validation Specialist must
maintain a professional manner and demonstrate initiative and
self-direction. This person must also be able to handle competing
priorities and executing projects with tight deadlines.


*Job Qualifications:  *Required experience: Validation, software
validation, computer system validation, 21 CFR Part 11: Minimum 5 years
• Thorough knowledge 21 CFR Part 11 regulations and guidelines
• Thorough knowledge of IT Controls methodologies
• Excellent communication skills, both verbal and written
• Detailed knowledge of the IT system development life cycle and software
quality assurance in a regulated environment
• Knowledge of general software and database concepts
• Experience with risk analysis and risk management practices and tools
• Knowledge of infrastructure technology and platforms
• The ability to work both independently and with teams at various levels
in the organization
• Excellent organizational skills and attention to detail and accuracy
• Five or more years of experience in computerized system validation within
a regulated environment
• Knowledge of Relsys EasyTrak SAP integrations and Crystal Reports a plus.


* Education  *• Required: Bachelor's degree in Computer Science or
Engineering discipline
• Preferred: Advanced degree in related technical field.

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Best Regards,

Kumar Gourav

952-546-3300 Ext: 5002

kum...@selectsourceintl.com

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