Experienced Business Analyst with ability to manage dynamic, tight timelines, and wield diplomacy and influence among various personality types.
Advanced system analysis skills an experience with one or all of the following: Veeva QMS, eTMF or RIM.
Must be adept in building document types, workflows, lifecycles, custom objects, and system configurations
Strong computer and presentation skills needed (Excel. PowerPoint)
Responsible for the extraction of system data for trending, reporting, expiry determination, and other user needs for Pharma Dev and regulatory filings.
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.
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 4 years’ experience in use, management, and/or validation of electronic systems in a GMP environment
Working knowledge of Veeva QMS, eTMF, RIM, MS Project, Word, and Excel
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
Experience in gathering, defining and refining requirements.
Experience in creating workflows.
Must have 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