Hi,
This is Arvind, - Recruitment and Resources from SancroSoft USA Inc.
We have an urgent requirement as follows:
Please respond with resumes in MS-Word Format with the following details to arvind@sancrosoftusa.com
Full Name :
Location :
Contact Number :
Email :
Availability :
Rate / Hour :
Visa Status :
Requirement Details
System Validation Test Engineer
Location : Rochester, NY
Duration : 3+ Months
• Experience in delivering FDA regulated Computerized System Validation, GAMP 5 and other related regulations (21 CFR Part 11 etc.)
• Good Understanding of related regulations of CSV in US, Canada, EU, Japan, China and other APAC countries
• Strategizing Validation approach complying with client QMS and Regulations.
• Authoring Master Validation Plans, preparing the 21 CF part 11 Assessments, Risk Assessments, and GxP Assessments, Validation Summary of computerized Systems
• Consulting the client and delivery teams on CSV aspects, including training, decisions on Validation, problem/issue reporting etc.
• Setting standards for technical writing, Validation testing etc.
• Reviews and approvals of CSV deliverables ( URS, SRS, SDS, Test plans, Test Scripts, Test Execution, Test Summary etc.)
• Any other CSV related activities
Thanks & Regards
Arvind,
Sr.Recruiter.
SancroSoft USA Inc | Direct: (916)-671-5686 | arvind@sancrosoftusa.com
4944 Sunrise Blvd, Suite B-4 | Fair Oaks, CA 95628 | Fax: (916) 200- 0305 | www.sancrosoftusa.com
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