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Ultragenic Research And Technologies logo
SENIOR CONSULTANT: CSV Ultragenic Research And Technologies

4.0 - 8.0 years

6 - 10 Lacs

noida

Work from Office

Working experience in CSV (Computer System Validation) in Life Sciences domain. Good knowledge of GxP regulations and GAMP 5 Guidelines. Must have experience and knowledge of 21 CFR part 11 and EU Annex 11 regulations. Experience in defining the validation strategy, approach, and alignment with customer on QMS. Good knowledge of good Documentation Practices. Experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice. Strong understanding of pharmacovigilance, regulations, guidelines for difference geographic location and Validating Safety Systems. Review...

Posted 1 day ago

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