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 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.
-
Reviewing & Authoring the CSV deliverables such as IQ, OQ and PQ scripts.
-
Experience of QA in FDA / EMEA regulated environment is preferred.
