*Hi All,*

* *

*Hope you are doing well!!!!*

* *

*Please Send me the suitable profiles to *

*sop...@datagrp.com** *

* *

*With **rate confirmation Contact Details with Current Location.***



*Candidates MUST BE local in NJ to go for in-person interview*



*Title:  Sr. Validation Specialist*

*Location: Princeton, NJ*

*Duration: 3 Months*

*Rate: $50.00/hr*

* *

Excellent communications REQUIRED

Candidates MUST BE local in NJ to go for in-person interview



*SAP VALIDATION IS REQUIRED***



*Excellent communication skills, both written and verbal. **
Attention to detail required.
Able to quickly grasp understanding of business needs and regulations that
may apply
Able to work independently with minimal supervision
Ability to work with both business and technical teams and at various levels
from developer to executive***

* *

* *

*6+ years experience**
• Apply FDA, MHRA, and other applicable global regulations to the
development of computer systems supporting regulated business processes
• Follow SOPs and industry best practices
• Conduct training on good documentation and good testing practices
• Facilitate the Computer system Validation Risk Assessment to identify
governing regulations and validation deliverables during the development of
the computer system
• Review validation deliverables for projects which are contracted to third
party suppliers
• Maintain close communication with stakeholders and team members to keep
apprised of computerized system needs, impacts on computer validation,
project validation status, and other relevant issues
• Assist in planning, implementing, and documenting user acceptance testing
• Review computerized systems validation documents such as:
o Requirements Specification
o Design Specification
o CSV Risk Assessment
o Test Plans
o Test Summary Reports
o Data Migration Plan
o Pre/Post Executed Test Scripts
o Traceability Matrix
o Release to Production Statements
• Direct and review testing
• Provide guidance on quality issues that affect the integrity of the data
or the system
• Prepare validation summary and test summary reports
• Obtain and respond to QA review
• Participate in establishing standard quality and validation practices
• Independently assess compliance practices and recommend corrective actions
• Approve validated computer system related change requests
• Monitor regulatory and inspection trends and advise the business on
suitable action*

-- 
Thanks & Regards,

Sophia Jones
Technical Recruiter
Data Group, Inc.
|Office: 1 – 732 – 791 – 2348 xtn: 250|
Fax: 732 – 907 – 1174 |
Email: sop...@datagrp.com|
Website: www.datagroupinc.net|

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