| Hi Hello , Hope you are doing well, My name is Shereen Unissa & I am with CodeForce 360 as US IT Recruiter. I am reaching for one of the positions I am working with my client. Request you to please find the attached job Description and advise if it interests you Location : Seattle, Washington Duration : 6 months (with possibility of extension) Client : Hitachi. REQUIREMENTS: - Serve as the technical and functional expert on the Veeva Vault applications (Clinical, Regulatory Information Management (RIM) , Quality Management System).
- Responsible for implementing configuration change requests on lifecycles, workflows, security settings, objects, and document types/subtypes.
- Provide Veeva administration and operational support including user and security management, hierarchies, roles, data management, workflows and report creation as necessary.
- Participate in requirements gathering efforts (Business Process/Functional and Technical Specifications) for the Veeva applications.
- Coordinate with Veeva Managed Services for Veeva product releases and resolution of any major issues in the application.
- Responsible for risk assessment of changes in the quarterly releases across all Veeva applications.
- Monitor alerts and troubleshoot critical production issues impacting end-users, including system unavailability and data integrity issues.
- Work directly with the support teams to bring open help desk issues to a resolution by triage and monitoring progress.
- Provide training support for new Veeva users.
- Oversee and participate, as needed, in system and user acceptance testing including IQ/OQ/PQ.
- Draft and lead IT Change Control Process as required for Veeva Vault Applications
- Responsible for the implementation and ongoing support of validated IT applications, including on-prem server-based applications, laboratory systems, and SaaS solutions.
- Complete upgrades and enhancements to existing applications
- Requisition application servers and assist in application installation
- Participate in GxP validation/qualification of systems including writing, reviewing, and executing validation protocols
- Create user documentation and train personnel on applications/reports/solutions, as required
- Develop effective working relationships with our internal customers and vendors during project meetings, on-site visits and conference calls
- Assists our internal customers in developing working scenarios for testing
- Communicate support issues, solutions and progress to management
- Manage the application integrations across Vault Quality landscape.
- Lead plan & deliver new and / or existing strategic platform capabilities that create tangible business value.
Preferred: - Previous experience supporting a Veeva Vault system, specifically, Veeva Vault Quality suite (QMS, QualityDocs, Audit and Risk modules)
- Familiarity with biotech/pharma business processes and applications
- Familiarity with GxP and ICH regulations and 21CFR, Part 11
Deliverables: - Process Flows
- Mentor and Knowledge transfer to client project team members
- Participate as primary, co and/or contributing author on any and all project deliverables associated with their assigned areas of responsibility
- Participate in data conversion and data maintenance
- Provide best practice and industry specific solutions
- Advise on and provide alternative (out of the box) solutions
- Provide thought leadership as well as hands on technical configuration/development as needed.
- Participate as a team member of the functional team
- Perform other duties as assigned.
| Skill Requirements | | | | | | | Rank | Standard Skill Requirements | Specific Details | Years | Ins. | Proficiency | | 1 | Application Architect | Previous experience supporting Veeva Vault Quality suite (QMS, QualityDocs, Audit and Risk modules) | 4 | 1 | Advanced | Thanks & Regards! Shereen Unissa Technical Recruiter Direct: (470) 333-0097 E-Mail: shereenu@codeforce.com LinkedIn: https://www.linkedin.com/in/sri-rajendra-turaga-3043aa17b/Your feedback is important to us and will help improve our recruitment process! Click here. CODEFORCE 360 | | | | |
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