{SAP JOBS USA:126056} Urgent Need: Sr. PQM/Validation Consultant // Fort Worth, Texas

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: vinay.kumar@saviance.com
Direct: 609-945-3426| Metuchen, New Jersey
www.saviance.com 

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