Executive Quality Assurance

Job Description:

Responsibilities

•  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 new regulatory and Abbott guidance / EQDs related to qualification.
•  To ensure compliance of qualification activities as per Abbott, EQD and AQ requirement

Qualification & Experience

• BSc/B. Pharma 3 +Yrs of experience.