Asst Manager - Quality Assurance (Validation)

1. Responsible for planning, Execution and documentation of Process Simulation (Media fill) activities in the facility.

2. Isolator qualification.

3. Terminal Sterilizer, Autoclave, Glove integrity tester, CCIT qualification.

4. Lyophilizer qualification.

5. Monitoring of Process Simulation (Media fill) activities during execution.

6. Responsible for preparation, review and updating of Media fill SOP and Media fill protocols.

7. Responsible to perform the periodic review of the filling interventions observed in the commercial batches since last media fill and execute the required changes (if any) in the next media fill.

8. To execute the Qualification / validation of equipment, utility and facility as per approved protocol.

9. Co-ordination with cross functional departments for qualification activities to ensure that completion of qualification as per pre-defined schedule.

10. Preparation & review of qualification protocols and handling of related change controls.

11. Preparation, compilation & review of qualification reports and to escalate any failure in a timely manner.

12. Tracking of master validation schedule/tracker on monthly basis to ensure the completion of qualification activities as per pre-defined schedule.

13. Ensure full compliance of FKOL procedures for outsourced qualification/validation activities, timely receipt of all documents from external service provider (including raw data and traceability certificate for calibration standards).

14. To perform the investigation in case of any failure and deviation during qualification activity.

15. Preparation and review of risk assessment, investigation and other quality system documents.

16. Responsible to maintain the training file and execution of training as per plan.

Operation and calibration of qualification instruments.

Regards,

Shikha Sharma

Manager - HR

shikha.sharma@fresenius-kabi.com

Baddi, Himachal Pradesh