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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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