| CSV Engineer at Remote, Remote, USA |
| Email: [email protected] |
|
http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=287008&uid= From: Arun kumar, yochana IT [email protected] Reply to: [email protected] CSV Engineer Bridgewater NJ Onsite(1-2 days a week) Contract Profiles Needed Minimum 4 years in CSV, having exposure in Medical Device/Med Tech sector, Pharma. Clear understanding of principle, procedures and governance of validation activities and IT controls Working Knowledge of regulations: 21 CFR Part 11 / 210/ 211 and Annex 11 Understanding of quality risk-management concepts (ICH Q9) Experience in systems validation and quality frameworks Perform quality review of relevant validation documentation pre and post execution for accuracy, completeness and ensures compliance with regulatory and client requirements. Experience in executing change control and document management Strong Knowledge of GAMP5 and Quality Systems Experience on decommission, Archiving and Data Integrity (ALOCA+) Experience in supporting Data Migrations from validation perspective Ability to communicate and work independently with Technical teams Adept with Agile and Waterfall methodology based software development and has prior experience in computer system validation using agile methodology Prior experience in using of tools like ALM, Document Management system (EDMS), ServiceNow and JIRA Thanks & Regards.... Arun kumar Yochana IT Solutions Inc., 23000 Commerce Drive, Farmington Hills, MI 48335 Desk : 248-618-2143 Email: [email protected] Keywords: information technology Michigan New Jersey http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=287008&uid= |
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| 03:59 AM 18-Jan-23 |