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