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Hi All,


Hope you are doing well!!!!


Please send me the suitable profiles to 


With rate confirmation Contact Details with Current Location.


ROLE:  Sr. Validation Analyst

Location: Wallingford, CT                                                       

Duration: 6+ Months

Rate: $ALAP 


Skills Required:
1. Validation
2. eCTD
3. Regulatory Submission applications
4. Pharmaceutical industry expeirence

      Sr Validation Analyst: Experience with eCTD and Regulatory Submission 

      . 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 

      . 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 

       . 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.

Certified Minority Women Owned Business Enterprise (MWBE) & Small Business 
Enterprise (SBE)


|Office: 1 - 732 - 791 - 2348 xtn: 250| Fax: 732 - 907 - 1174 |Email:|Website:|


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