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.
- 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
- 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.
- 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