Hi Folks,
Please share the suitable resource for this Position.
Please share the Visa Copy and Photo ID Proof of your consultants. at
*manish.gu...@nityo.com
<manish.gu...@nityo.com>*
=================================================================

*Role: Trackwise EQMS Tech Lead*
*Location: New York, NY*
*Duration: 3-6 Months*

*Description:*

*Qualifications Basic*
• Bachelor’s degree or foreign equivalent from an accredited institution or
three years of progressive experience in the specialty in lieu of every
year of education.
• At least 8+ years in Information Technology.

*Technical Skills*
• Experience with Trackwise 7 or 8.
• Good knowledge to Configure workflows to meet requirements
• Analyze requirements to recommend approaches for building and changing
workflows
• Sparta Certification or equivalent (Good to have)
• Experience with Complaint Handling, CAPA, Audits,
Deviations/Investigations implementation (At least two implementations)
• Good understanding of Regulatory Reporting, TrackWise Coordinator,
TrackWise Migrator
• Trend and impact analysis to recommend remediation/improvements based on
their implications on IT maintenance and business use.
• Experience with ITIL philosophy and SDLC methodologies.
• Strong knowledge on Oracle PL/ SQL.
• Strong knowledge on Crystal Reports.
• Good knowledge on Java, J2EE technologies.
• Good knowledge of migrations from source systems to target ( TrackWise )
based systems
• Good understanding of business concepts and experience as a developer in
a regulated environment.
• Prior experience of working in a large scale support and maintenance
environment.
• Excellent and matured communication skills required at client side and
interpersonal skills.
• Understanding of Good Documentation Practice (GDP)
• Familiarity with Clinical, Pharma & Regulatory compliance domain would be
a plus point.
• Ability to understand domain and provide value additions or improvements.

*Roles and responsibilities*
• Work with business users to understand the issues and business processes
• Address technical issues whenever required.
• Review and test the deliverables before handing to clients.
• Provide regular updates to the customer on the ongoing work.
• Provide technical solutions to the problems/enhancements.
• Client management and coordination with various stakeholder teams in the
project

*Mandatory skills:*
• Experience with Complaint Handling, CAPA, Audits,
Deviations/Investigations implementation (At least two implementations)
• Strong knowledge on Crystal Reports.
• Good knowledge of migrations from source systems to target ( TrackWise )
based systems


Thanks & Regards!
*Manish Gupta*
*Desk : **609-853-0818 **Ext. 2130*
*Email : manish.gu...@nityo.com <manish.gu...@nityo.com>*

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