Hi,

Please find the below requirement and if interested then send me updated
resume along with contact details ASAP.****

*Role: *Sr. PQM/Validation Consultant*
**Location: *Fort Worth, Texas
*Duration:* Long Terms

*Job Description:
**=============================================
*·         Understand and adhere to the Quality manual, SOP on Project
Management, Change Management, Document Management and Quality Management;
·         Support the Project Manager throughout the project delivery of
the Enterprise Asset Project, with regards to aspects of project related
risk, compliance and quality.
·         Responsible together with Project Manager for the delivery of all
defined QM documentation
·         Establish, implement and monitor the QM requirements which
assures that IT Projects meet Quality and Regulatory requirements
·         Apply required internal and external Quality/Compliance standards
to work products (Change control, validation documents etc)
·         Ensure adequate analysis have been performed for relevant testing
conditions based on functional risk assessment, test overview list, test
plan, test results, test deviations and change requests.
·         Train and coach the project team, as required, on relevant
project procedures, good documentation practice, good testing practice and
CSV basics, where applicable
·         Manage appropriateness of preparation and readiness of the
project for handover of the system/processes to the operational
organization together with the project managers
·         Perform the project tollgate reviews and post implementation
reviews with reporting to management

*Experience:
*·         5-8 years relevant work experience in IT/QM compliance
·         Excellent English communication skills, both written and oral,
additional languages would be a plus
·         GxP, 21 CFR Part 11, SOX, SOX IT knowledge
·         System Development Life Cycle and Gamp Knowledge
·         Sound Knowledge in SAP or played a role of PQM for SAP
Implementation projects
·         Able to manage direct relations with stakeholders and project
team members

*Good to Have:
*·         Novartis experience and knowledge on ICE Methodology.

** **

Thanks & Regards
Vinay | Technical Recruiter |Saviance Technologies|
Email: [email protected]
Direct*: 609-945-3426| **Metuchen**, New
Jersey*<http://en.wikipedia.org/wiki/Metuchen,_New_Jersey>
*
*www.saviance.com

[image: 
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