Hi Folks,
Please share the suitable resource for this Position.
Please share the Visa Copy and Photo ID Proof of your consultants. at Manish.gupta@nityo.com
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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:
• 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
• 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.gupta@nityo.com
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