SENIOR CONSULTANT: CSV (Experience: 4 to 6 Years in CSV)

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.