Key Accountabilities:

1. Prepare Data required by regulatory inspectors.
2. Update the data of the concerned warehouses to be presented to the regulatory inspector.
3. Participate in preparation and Handling of external and internal audits.
4. Support in planning of the meetings and prepare minutes related to regulatory inspections.
5. Coordinate with other departments and compile the data required for regulatory submission.
6. Prepare, receive, store and submit the required samples for testing by regulatory bodies.
7. Prepare the data required for approval of holed batches due to Variation, Validation Random withdrawal, Drug shortage, FMS, Registration, Market Surveillance, pilots, New Supplier evaluation,…..
8. Review data required for qualifications and approval of new suppliers.
9. Backup person for the QA compliance tasks (Deviation/Change Control/Complaint/Recall/OOS/NCR/CAPA/QRM)
10. Update concerned department with any regulatory requirements/Update.
11. Coordinate any Conformance / non-conformance to concerned stakeholders
12. Prepare reports and minutes for the withdrawal of API and FP to be presented to the EDA inspector
13. Distribute status reports and output of EDA regulatory inspection to all relevant departments internally
14. Document & archive all the files as per the set procedure.
15. Prepare various requests that need to be sent to the Inspection Department of the EDA to obtain certain approvals
16. Follow-up of the approval of authority for API and FP.
17. Organize and perform own work tasks and assist coordinating activities.
18.  Any other related task may be assigned by QA Supervisor/Manager/Director.

Qualification Requirements:

• BSc. Science (Chemistry / Physics).
• Good communication skills.
• Very good computer skills.
• Fluent in English (reading & writing).
• Experience from 1 to 3 years.