System Validation Test Engineer ::::: Rochester, NY ::::: 3+ Months

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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