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Veeva QualityDocs Data Migration Lead

South San Francisco, California · Biotech/Pharmaceutical
Title: Veeva QualityDocs Data Migration Lead / Business Analyst
Duration: 6 months contract
Location: 100% Remote


This individual will coordinate the document data migration / document repository into Veeva QualityDocs. This person will be working with the business to manage the data migration project. Must have extensive experience with Veeva QualityDocs.
 
Primary Skills
  • Business analyst with ability to manage dynamic, tight timelines, and wield diplomacy and influence among various personality types.
  • Advanced system analysis skills and experience with Veeva QualityDocs is a must-have
  • Experience with DocuSign is a plus
  • Must be adept in building document types, workflows, lifecycles, custom objects, and system configurations
 
Responsibilities:
  • Responsible for the extraction of system data for trending, reporting, expiry determination, and other user needs for Pharma Dev and regulatory filings.
  • System Analysis on Veeva QualityDocs system and QMS.
  • Ensure that GxP systems that are used to create, modify, or maintain electronic records and/or electronic signatures are maintained in a validated state in accordance to Customer’s Software Development Life Cycle (SDLC)
  • Support processes to meet 21CFR Part 11 and Annex 11 standards that will allow the customer to effectively manage information flow and data collection, and review activities of multiple systems.
  • Work collaboratively with internal analytical teams and contract research organizations (CRO) to resolve data management related issues.
  • Provide status reports to internal team on the progress of electronic data supporting projects/programs.
  • Participate in electronic systems procedure audits of contract labs to ensure compliance with corporate procedures and with 21CFR Part 11 requirements.
 
Other Requirements:
  • A Bachelor’s Degree in Computer Sciences, Pharmaceutics, Chemistry, Statistics, Biology or related field with a minimum of 5 years’ experience in use, management, and/or validation of electronic systems in a GMP environment
  • Strong skills in gathering, defining and refining functional and technical requirements
  • Experience demonstrating skill sin business systems analysis of software development life cycles (SDLC), change management and capacity planning best practices.
  • Familiarity with GAMP 5 implementation methodologies and risk assessments
  • Working knowledge of Veeva QualityDocs, QMS, MS Project, Word, and Excel
  • Experience in gathering, defining and refining requirements. 
  • Experience in creating workflows.
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
  • Must possess strong customer service orientation and an understanding of business processes related to pharmaceutical corporate activities.
  • Strong oral and written communication/presentation skills
 
 
 

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