SENIOR CONSULTANT: CSV
(Experience: 4 to 6 Years in CSV)
Roles and responsibilities:
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 positive 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.
Solid understanding of pharmacovigilance, regulations, guidelines for difference geographic location and Validating Safety Systems.
Reviewing & Authoring the CSV deliverables such as IQ, OQ and PQ scripts.
Experience of QA in FDA / EMEA regulated workplace is preferred.
📌 Senior Consultant: Csv Experience: 4 To 6 Years In Csv Noida
🏢 Ultragenic Research & Technologies
📍 Noida
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