| : IT Validation Specialist::Cambridge, MA ( Local Only ) at Cambridge, Massachusetts, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=605892&uid= From: Anwesha Singh, Cloud Think Technologies [email protected] Reply to: [email protected] Title: IT Validation Specialist Location: Cambridge, MA ( Local Only ) Duration: 6 months, could extend Visa: USC and GC Domain- Pharma Job Requirements: Knowledge of science biology, chemistry, engineering, or related discipline is preferred, or its equivalent. Experience working in a GxP regulated environment, preferably in the biopharma space. Experience working with users from the quality, clinical, and regulatory domain Knowledge and Skills: Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints. Comprehensive understanding of the Software Development Life Cycle, GAMP 5 and regulatory agency requirements. Knowledge in following areas: Project management User requirements analysis Data management and software configuration/administration Software validation testing and documentation Incident or issue management Periodic reviews and release management support Preferred domain knowledge: Domain knowledge of Quality, Clinical, and Regulatory processes Veeva Systems Experience which includes Veeva Quality and Regulatory Vault. perform change management activities in support of system enhancements and user requirements design solutions and manage configuration configure and manage integrations to Vault platform participate in the development of solutions and manage project/change timelines troubleshoot user issues author validation deliverables author Standard Operating Procedures and Work Instructions provide user trainings provide technical solutions to requirements that encompass best practice, efficiency and global considerations Strong ability to comprehend complex problems and apply knowledge to propose potential solutions. Analytical skills to be able to understand the needs of customers and work out priorities. Strong written and oral communication skills as well as organizational skills. Demonstrated ability to work effectively under established guidelines and instructions. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Major Duties and Responsibilities: Provides application validation support, documentation, training, and troubleshooting of Veeva systems that includes quality, clinical, regulatory systems which includes Veeva Quality (QDocs, QMS, LMS), and Regulatory (RIM). Communicates issues, technical failures, and projects status updates to direct manager. Review and implement change controls associated with these applications Perform project management activities in support of business process improvements. Thanks and Regards Anwesha Singh Technical Recruiter Cloud Think Technologies E: [email protected] Website: www.cloudthinktech.com LinkedIn: https://www.linkedin.com/in/anwesha-singh-225a28221/ Address :12301 Kernan Forest BLVD APT 1407, Jacksonville FL, 32225 Please consider the environment before printing this e-mail. DISCLAIMER The information in this e-mail is confidential and may be legally privileged. It is intended solely for the addressee. Access to this e-mail by anyone else is unauthorized. If you have received this communication in error, please notify the sender and delete the e-mail and destroy any copies of it. If you are not the intended recipient, any disclosure, copying, distribution or any action taken or omitted to be taken in reliance on it, is prohibited and may be unlawful. Any opinions or advice contained in this e-mail are subject to the terms and conditions expressed in the governing Cloud Think Technologies client engagement letter. Opinions, conclusions and other information in this e-mail and any attachments that do not relate to the official business of the firm are neither given nor endorsed by it. Keywords: information technology green card Florida Massachusetts http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=605892&uid= |
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| 07:45 PM 06-Sep-23 |