Hope you are doing well!!!!
Please Send me the suitable profiles to
With rate confirmation Contact Details with Current Location.
Position: Sr Validation Analyst
Location: Central, NJ (Locals Preferred)
Bill Rate: Rate: $60/hr
Duration: 6-12+ Months
US Citizen or GC/EAD and H1's
Pharmaceutical Experience is a MUST!
Must have knowledge of Software Validation Life Cycle and the document
deliverables associated with the life cycle.
This individual must have Quality Assurance experience in the area of review
and approval of validation documentation as they pertain to a set of
requirements and procedures.
Having Maximo experience is a plus.
. 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
. Review validation deliverables for projects which are contracted to third
. 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
. 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
Thanks & Regards,
Data Group, Inc.
Certified Minority Women Owned Business Enterprise (MWBE) & Small Business
|Office: 1 - 732 - 791 - 2348 xtn: 250| Fax: 732 - 907 - 1174 |Email:
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