Followings will be the responsibilities of the position holder:
- Preparation and review of qualification and Validation documents (URS, DQ, IQ, OQ, PQ, etc.) for ODF Facility.
- Preparation and updation of Validation Master Plan, CVMP, SMF, Quality Manual and planner for ODF facility.
- Execution of qualification and requalification activities for ODF facility.
- To review plant layouts and drawings for ODF facility.
- To perform decommissioning study of equipment’s for ODF facility.
- To perform activity in software Darius, ISOtrain, and SolTRAQ for ODF facility.
- Co-ordination with other departments for streamlining qualification activities for ODF facility.
- Execution of process validation protocols for ODF facility.
- Monitoring of calibration activities and review of related documents.
- Preparation of SOP, training modules on validation and execution of training sessions for ODF facility.
- Review of Calibration and Preventive maintenance related documents.
- Execution of Qualification/Validation activity for critical utilities e.g., compressed air, nitrogen, HVAC/area validation, Purified Water.
- Preparation, execution of documents related to computer system validation for ODF facility.
- Perform QRM for qualification activities for ODF facility.
- To initiate and review the change control activity for ODF facility.
- Implementation of recent regulatory and Abbott guidance / EQDs related to qualification.
- To ensure compliance of qualification activities as per Abbott, EQD and AQ requirement.
In absence of the position holder the subordinate Peer Manager working in section, shall be responsible for day to day working.