Team Leader - QA Validation - Sterile

Responsibilities:

1. Review of URS, IO, OQ,DQ and PQ document of Isolator, vial washing machine, Tunnel, filling machine, sealing machine , lyophiliser and Autoclave

2. Review of risk assessment

3. Review of HVAC qualification documents

4. Smoke study review

5. Sampling of process Validation samples, Hold time study samples and Cleaning Validation Samples.

6. Preparation and review of cleaning validation protocols. Reports and summaries along with monitoring and execution of the validation activities as per approved protocol.

7. Preparation, review of hold time study validation protocols, reports, and summaries along with monitoring and execution of the validation activities as per approved protocol.

8. Preparation, review of water system validation protocols, Reports, and summaries along with monitoring and execution of the validation activities as per approved protocol.

9. Preparation, review of Compressed air validation protocols, Reports, and summaries along with monitoring and execution of the validation activities as per approved protocol.

10. Preparation, review of non-routine validation protocols, Reports, and summaries along with monitoring and execution of the validation activities as per approved protocol.

11. Preparation, review of Process Variable Impact Analysis validation protocols, Reports, and summaries along with monitoring and execution of the validation activities as per approved protocol.

Preparation, review of Computer system validation protocols, reports, and summaries along with monitoring and execution of the validation activities as per approved protocol.