| Validation Analyst with Regulation at Remote, Remote, USA |
| Email: [email protected] |
| From: Sonu Uprati, ValiantIQ Inc [email protected] Reply to: [email protected] Title: Validation Analyst with Regulation Raleigh, NC Hybrid Pharma 5 0hr c2c max Not looking for more than 6 years overall experience Mandatory skills: Validation Analyst Medical device computer systems validation SaaS, compliance, FDA requirements Risk assessment, testing, documentation Subject matter experts, 21 CFR Part 11 requirements Description: Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Excellent knowledge of GxP regulations, FDA and EMEA (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11. Excellent knowledge of computer system validation and GAMP -5 standards. The client is looking for the below: Responsible for following ADC quality system procedures for non-product computer systems validation, primarily SaaS validation. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Looking for significant experience in medical device computer systems validation. Including project management, risk assessment, requirements definition, testing and all documentation. Identifying and working with / taking directions from system owners, subject matter experts, and quality approvers. Must have significant experience in medical device computer systems validation, including SaaS, in compliance with FDA requirements. Must have experience with validation of 21 CFR Part 11 requirements. Thanks & Regards, Sonu Uprati Technical Recruiter- ValiantIQ Inc . "Searching Best Minds Searching Best Minds" Email: [email protected] F. (302) 482-3672 Disclaimer: If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line for automatic removal. And mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience. Keywords: North Carolina Validation Analyst with Regulation [email protected] |
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| Fri Aug 16 22:10:00 UTC 2024 |