QA-validation - Pharma

2 days ago

Gajularamaram Hyderabad Telangana, India Amogen pharma pvt ltd Full time

1. Preparation of Qualification Documents User Requirement Specification, System risk assessment, Risk assessment, Design qualification, Installation Qualification, Operational Qualification, and Performance Qualification.

2. Responsible for execution of Factory acceptance Test.

3. Responsible for execution of mechanical completion checklist and provide clearance for equipment qualification.
- 4. _Execution of Qualification activities Installation Qualification, Operational Qualification and performance qualification_._

5. Preparation and review of performance verification protocols and reports.

6. Review of Engineering related documents, Preventive maintenance, and calibration schedules.

7. Preparation of Equipment and area performance verification yearly and monthly planners.

8. Review of all departments Breakdowns and notifications and alarms.

9. Review of SOPs related to engineering and water plants.

10. Review of Change controls related to equipment.

11. Review of Protocols and Reports.

12. Review of Layouts related to facilities.

13. Periodic Review of Audit trails of equipment.

14. Responsible for computer system Validation related activities and its execution.

15. Responsible for Supporting engineering team for cleaning validation and verification activities

Responsible for maintenance of all qualification documents of equipment and planners.

**Job Types**: Full-time, Permanent

Pay: ₹20,000.00 - ₹30,000.00 per month

**Benefits**:

- Food provided
- Health insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift

Work Location: In person

**Speak with the employer**
+91 9000228231

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