| Business Analyst EDMS GXP at Remote, Remote, USA |
| Email: [email protected] |
| From: Love kr, USG [email protected] Reply to: [email protected] Title: Sr. Business Analyst EDMS/ GXP Location: Remote Contract Description: Experience as a Business Analyst (BA) in a GxP-compliant project within the Life Sciences or FDA-regulated pharmaceutical manufacturing industry. Preferably, familiarity with Document Management Systems or Quality Management Systems/Laboratory Information Management Systems. Role Scope / Deliverables: Understanding of Greenville Batch processing and GXP process Ability to correlate the Greenville process to eDMS Functions. Knowledge of EDMS generic processes to assess and recommend process improvement/simplification Interact with Various teams to understand their process and document the requirements. Explain the Functional requirements to Development team for System Requirements Review and Dry run Test Scripts to ensure Traceability of requirements. Drive Change Management for the project Conduct walks thru sessions to explain How requirements are implemented. Collect/track user comments/issues through out the project and ensure closure. Inputs to Data Migration Plan Prepare URS / FRS documentation for ALM Coordinate SMEs/Tester and Conduct Testing (OQ/PQ) in HP ALM Coordinate Communication Plan for Site Formulate Cut-Over Plan , Back Up process etc., along with IT Communicate and Coordinate Data Collection and Data enrichment with Site. Conduct Training sessions (if required) Inputs to SOP creation and Training Materials Key Skills: 8+ Years of Experience in the following... Experience with EDMS (or any Content Management System/principles) Understanding of Batch Processing /Master Batch Records Experience working as a Business Analyst Understand Change Management Experience with GxP and Validation Processes Working on GxP Validated Projects and Producing Deliverables Experience writing SOPs for GxP Projects Experience using HP ALM in Requirement and Tester related roles Thanks & Regards Love Kumar Technical Recruiter United Software Group Inc. 6000 Venture Dr, Suite C & D, Dublin, Ohio 43017, USA Direct: 614-953-8690 || 609-531-4354. Office Number: (614) 495-9222 Ext: 484 [email protected] Keywords: cprogramm business analyst information technology hewlett packard Business Analyst EDMS GXP [email protected] |
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| Tue Sep 24 02:17:00 UTC 2024 |