| Sr. Validation Engineer (CSV) || Around 10-12 years of overall experience at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2027662&uid= From: Nitish, Arkaya Infotech Inc [email protected] Reply to: [email protected] Position: Sr. Validation Engineer (CSV) Hybrid at Oceanside, California Looking for profiles having around 10-12 years of overall experience Skill competencies At least 10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality Demonstrated project management and leadership skills Proficiency in interacting with contacts, including project teams and vendors Certified auditor or equivalent experience conducting software-vendor quality audits Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP Experience with the following software systems/applications: Quality Management System Document Management System Validation Management System Bachelors/Masters degree in Computer Science Engineering or equivalent Regards, Nitish Lead IT Recruiter Arkaya Infotech Inc. Keywords: information technology Sr. Validation Engineer (CSV) || Around 10-12 years of overall experience [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2027662&uid= |
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| 07:56 PM 19-Dec-24 |