Computer System Validation Executive

2 weeks ago

Ahmedabad, India Veeda Clinical Research Limited Full time

1. To define & drive the CSV strategy / plan to achieve the validated status during project stage as per the SOP

2. Perform Risk assessment and carry out Risk based testing of Computerized System

3. Preparation and Review of Validation deliverables such as URS, GxP, VP, Specifications documents(SDS, FS, SCS), IQ Protocols and Scripts, OQ Protocols and Scripts, PQ Protocols and Scripts, TM and VSR as per the SOP

4. Execution/Support in execution of IQ, OQ and PQ test scripts

5. Co-ordinate with Vendor and System owner to carry out Validation activity of Computerized Systems and Software

6. Responsible for achieving & maintaining the validated status of in scope computerized systems

7. Other Responsibilities assigned by Reporting Manager or Designee

8. Periodic review of all GxP Software in Company

9. Responsible to response to Audit query for the software by Regulators and Sponsors

10. Responsible to face Internal Audit for Software

11. Active member for External Audits faced by Company

**Salary**: ₹15,819.00 - ₹29,899.00 per month

**Benefits**:

- Flexible schedule
- Health insurance
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund

Shift:

- Day shift

Ability to commute/relocate:

- Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

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