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 valuable 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.

📌 SENIOR CONSULTANT: CSV (Experience: 4 to 6 Years in CSV) (India)
🏢 Ultragenic Research & Technologies
📍 India