Validation Lead Consultant
The validation lifecycle includes capturing Business and Functional requirements, developing Trace Matrix, assessing Risks, developing and executing Validation Scripts and preparing Validation Summary
- Good experience in CSV (Computer System Validation) / Software Testing in the pharmacovigilance domain.
- Development, Execution, Approval, and Monitoring of the Qualification (Validation Plan, IQ, OQ, PQ, RTM, summary report) deliverables for GAMP.
- Well-versed with SDLC models and Software Test life cycle.
- Documentation management.
- Strong Understanding of pharmacovigilance, regulations, and guidelines for different geographic locations.
- Good understanding of RDBMS and SQL queries.
- Experience of QA in FDA / EMEA regulated environment is preferred.
- Life Sciences
- Pharmacovigilance & Bioinformatics
- Job Level
- ₹ 3,00,000 - ₹ 13,00,000
- 2 - 6 (in years)
- Uttar Pradesh
- Reporting To
- Company Name
- PV technology solutions
- Company Size