Executive -Quality Assurance

Job Description

1. Comply with all cGMP, GxP, or any other regulatory requirements, including EH&S requirements.
2. To prepare/revise validation protocol and prepare validation reports related to equipment, facility, utility, process and cleaning validation undertaken across the site in close coordination with engineering, production and other concern in line with the corporate validation guidelines.
3. Preparation, review and approval of quality system document related to qualification and validation.
4. Preparation and review of validation master plan and validation planner.
5. To ensure all cleaning validation, equipment/system qualifications and temperature mapping activities are carried out as per protocol/schedule in line with GMP requirement.
6. To ensure all the relevant documents are compiled as per GMP requirement prior to approval of any validation document.
7. To participate in validation/qualification processes as and when required and ensure that the execution is going on as per approved protocols.
8. To update/revise SOP related to validation/qualification in line with various guidelines.
9. Monitoring and review of Qualification / Validation activities.
10. Handling of QAMS activity.
11. Handling of E-log
12. Handling of EDMS   
13. Handling of SAP activity.
14. Handling of Deviations, Change controls, CAPA, OOS, OOT, Failure investigations, Reprocessing and Reworking.
15. Preparation and review of annual product quality review, trends report, stability protocol.
16. To perform periodic review of logbook.

Work Experience

6 to 10 years

Education

Competencies