Urgent requirement
Please send resume @ bipin@tresourceinc.com
Hi,
I have an urgent requirement with one of my clients, details given below. If you find yourself suitable for the position, please send me your latest updated resume along with contact details. Please include your employer details as well.
| Job Title | Software Validation Engineer |
| Project 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.
Thanks & Regards
BIPIN RAJ
Sr. US IT Recruiter (Talent Acquisition)
Technology Resource Group Inc
3736 Hills-Dale Court,
Santa Clara, CA 95051
Direct: 408-709-1760 Ext : 818,
G talk: bipin.rgtalent@gmail.com
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