Job Description

Role: CSV and Compliance Expert

Experience: 2-4 years in any CRO/Pharma

Location: Hyderabad

1. Be a Subject Matter Expert on computer system validation and data integrity requirements
compliance.
2. Write and perform evaluations, reviews, risk assessments and testing of computerised
systems considering the principles of GAMP5, 21 CFR Part11, EU Annex 11 and OECD along
with internal procedures.
3. software validation and revalidation activities like preparation and execution of validation
documentation including risk assessments, IQ, OQ, PQ Protocols and reports and traceability
matrices, and validation reports.
4. Preparation of Standard Operating Procedures (SOP’s).
5. Represent compliance team for all sponsor/regulatory audits and related queries
6. Reviewing vendor validation documentation & co-ordinating the validation and
troubleshooting activities.
7. Software administration and maintenance support (Empower, Watson LIMS, Analyst, and
other lab applications).
8. Perform BCP/DRP activities for computerized systems
9. Perform Periodic Review of the Computerized Systems
10. Maintain up to date Software inventory.