CSA and CSV practitioner

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Job Title: CSV Lead Location - Remote Mandatory Skills - LIMS Lab Vantage & CSV Job Summary: Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.Knowledge of FDA guidances and industry standards (i.e., GAMP)Experience in writing and executing documentation for all aspects of the validation deli

Job Title: Computer System Validation (CSV) Manager Work Location: Indianapolis, IN (Remote is fine for now) Contract duration: Long-term contract Visa: /Only Job Details: Mandatory Skills: - IT CSV Validation of IT systemsIT QA / QA eCompliance ManagerExperience with Veeva Quality Docs, ServiceNow, JIRA, and ALMPharma industry experience is mandatory.Medical device experience is good to have.Safety / PharmacovigilanceClinical trial management systemsGoogle Cloud Platform / GVP

Job Role: Business Analyst with Project Management (BA/PM) Location: Cambridge MA - Remote Mode: Long Term Project Job Required: We need emphasize on Gxp, CRO, Biotech, change requests, requirement traceability matirx, decommisioning applications, small projects , vendor management and stake holder management.10+ years of combined experience in Life Sciences IT, including:Minimum 5 years in a GxP-regulated system administrator or support capacity.Minimum 5 years in project management, delivering