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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.
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
Description
Sr Validation Analyst: Experience with eCTD and Regulatory Submission
applications
. 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.
Certified Minority Women Owned Business Enterprise (MWBE) & Small Business
Enterprise (SBE)
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|Office: 1 - 732 - 791 - 2348 xtn: 250| Fax: 732 - 907 - 1174 |Email:
sop...@datagrp.com|Website: www.datagroupinc.net|
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