| CSV Engineer- Bridgewater NJ(Hybrid) at Bridgewater, New York, USA |
| Email: [email protected] |
| From: Sai Krishna, ICONIC Infosys Inc [email protected] Reply to: [email protected] Greetings from ICONIC Infosys Inc!! ICONIC Infosys Inc is an IT Development & IT Staffing firm with more than a decade of experience in providing IT Staffing Solutions & Services. Our expertise is in sourcing and deploying highly skilled IT Specialists into mainstream and niche technologies to meet clients Temporary, Permanent & SOW project needs. Role: CSV Engineer Location: Bridgewater NJ Onsite(1-2 days a week) Duration: Long Term Job Description: Minimum 6 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 Best Regards, Sai Krishna Technical Recruiter Email: [email protected] www.IconicInfosys.com Keywords: information technology New Jersey |
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| Tue Jan 17 23:26:00 UTC 2023 |