Hi,

 

Please check the below requirement and advise us the right consultant's
along with Rate, Availability, Contact Details, Current Location & Visa
Status.


Senior Validation Specialist

 

Location: Princeton, NJ

 

Duration: 6 months

 

Rate: $42/hr C2C

 

Individual to provide support for SAP Support Pack implementation project

 

Required Skills:

. 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,

Raj
 
TECHGENE SOLUTIONS, LLC
(A Minority Certified Company)
Email: [email protected]
Ph: 214-257-0837 extn: 36
Fax: 972-692-5824
www.techgene.com <http://www.techgene.com/> 
Yahoo IM: [email protected]  
 
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Thank You.

 


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