About the role
1.Responsible for review of user requirement specification, design qualification, FAT protocols, SAT protocols, installation qualification, operational qualification, performance qualification protocols and reports.
2.Responsible for preparation of commissioning protocols, FAT, SAT and associated risk and gap analysis documents.
3.Responsible for preparation of facility, equipment, area qualification protocols and reports.
4.Accountable for facility, utilities, equipment and area qualification activities.
5.Responsible for validation activities of autoclaves, manufacturing vessels, centrifuge, filterpress, vial washing, depyrogenation tunnel, filling & sealing machines, HVAC system etc.,
6.Responsible for validation activities of autoclaves, manufacturing vessels, centrifuge, filter press, vial washing machine, depyrogenation tunnel, filling and sealing machines, HVAC systems etc.
7.Accountable for ensuring the compliance the qualification activities in-line with quality/regulatory requirements.
8.Responsible for Engineering compliance and review of Engineering department SOPs, PM, calibration and facility maintenance schedules.
9.Responsible for review of facility and equipment drawings.
10.Responsible for monitoring and review of computerized system validation.
11.Responsible for monitoring and review of risk assessment, incidents and change controls related to Qualification and Engineering and other cross functional departments.
12.Perform or coordinate process and cleaning validations.