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Position Details: SAP Validation
| Location: | Gurgaon, Haryana |
| Openings: | 1 |
| Salary Range: | 12 LPA |
Description:
ROLE SUMMARY
Coordinate and lead SAP Computer System Validation (CSV) activities to ensure SAP and its integrated systems are in full compliance with regulatory requirements, company policies, and procedures.
Serve as the subject matter expert to provide compliance oversight to SAP Team.
Key Skills:
- Should have validation experience of SAP system in Pharma domain.
- Good Understanding of Business processes in SAP.
- Understanding of 21CFR Part11 and GAMP 5.
RESPONSIBILITIES:
- Prepare, review, and approve various computer validation documents for SAP CSV projects as below:
- Validation Plan
- Technical Documentation (e.g., User Requirement, Functional Requirements, Design Specifications
- Review of Functional and Technical Specification
- Requirements Traceability Matrix
- Risk Assessment
- IQ/OQ/PQ Protocols, test scripts (Pre and Post)
- Validation Summary Report
- Perform Pre and post review and approval of validation test scripts including test defects.
- Ensure a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to SAP System within CSV responsibility.
Perform an action:
