QA Validation – Senior Executive

Roles and Responsibilities

1. Responsible for planning, organizing and executing of periodic re-qualification activity of
equipment and system.

2. To review protocol and reports of periodic re-qualification of process equipment and
miscellaneous study.

3. To review protocol and reports of Cleanroom/ Heating, ventilation and air conditioning system
protocol as per regulatory and ISO Standards.

4. To review the URS, design qualification, installation qualification and operational qualification
protocol.

5. To prepare and execute performance qualification protocol and report.

6. To review protocol and reports of temperature mapping periodic re-qualification.

7. To plan and co-ordinate with cross-functional department for smooth execution of
qualification and validation activities.

8. Responsible for review of technical specification of newly procured equipment and instrument
w.r.t QA Validation / Qualification prospective.

9. Responsible for review of FAT protocol and execution of FAT of new equipment and system.

Execution of computer system validation (SCADA/PLC/Lab Software)