| GxpTechnical Validation Business Systems at Cambridge, Massachusetts, USA |
| Email: [email protected] |
| From: Akash Sharma, Tek Inspirations [email protected] Reply to: [email protected] Job Title: Gxp Technical Validation Business Systems Location: Cambridge, MA-Hybrid Duration: 12 Months MOI: Slype Need to be local of MA Job Duties Authors IT validation documents for hardware and software, manages document review and approval workflows Performs the analysis of complex business problems and manages business requirements within area of responsibilities Performs system administration duties as needed to support the setup and validation of GxP hardware and software Experience gathering business requirements, software testing (UAT, IQOQ), creating and writing SOP's and GXP validation documentation (includes but not limited to User Requirements Specs, System Design Documents, IT System Administration Guides) Interface and liaise between IT, Business (all levels of lab staff and management) as well as Third Party vendors Create technical system design deliverables (data flow diagrams, network architecture) through independent research and interviews with technical subject matter experts Expertise and experience working on and validating a cross section of lab systems (for example, NC-200, XURI (Unicorn), Met One, BACT/MYLA, FACSDiva) Experience within CFR Part 11/GxP software qualification Understanding of data management for gxp systems Implementing and managing data integrity across lab and enterprise systems Data resiliency backup, restore, archive Audit trails Performing annual account reviews, periodic reviews Performing GMP data quality assessments and managing deviations Managing document review and approval workflows in a global document management system Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs) Manage IQOQ and UAT write and execute test scripts, author test summary reports Experience with Agile, Scrum, and Kanban concepts Nice to have - experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings with asset lifecycle management and environmental monitoring systems Authors IT validation documents for hardware and software, manages document review and approval workflows Performs the analysis of complex business problems and manages business requirements within area of responsibilities. Performs system administration duties as needed to support the setup and validation of GxP hardware and software Bachelor's degree in Computer Science, Engineering, or a related field Minimum of 3 years of experience working as a Business Systems Analyst or Validation Analyst in a GxP regulated environment Strong understanding of GxP regulations and FDA guidelines, including 21 CFR Part 11 Experience in designing and executing validation protocols and documentation Requirements Bachelor's degree in Computer Science, Engineering, or a related field Minimum of 5 years of business analysis experience and 3 years software and hardware validation experience in a GxP regulated environment Strong understanding of GxP regulations and FDA guidelines Experience in designing and executing validation protocols Excellent communication and interpersonal skills Detail-oriented with strong analytical and problem-solving abilities Ability to work independently and manage multiple priorities Knowledge of Agile methodologies is a plus Keywords: information technology Massachusetts North Carolina |
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| Tue Feb 13 03:29:00 UTC 2024 |