What are the responsibilities and job description for the Quality Assurance Specialist position at PHARAONIA PHARMACEUTICALS?
Key Accountabilities:
- Prepare Data required by regulatory inspectors.
- Update the data of the concerned warehouses to be presented to the regulatory inspector.
- Participate in preparation and Handling of external and internal audits.
- Support in planning of the meetings and prepare minutes related to regulatory inspections.
- Coordinate with other departments and compile the data required for regulatory submission.
- Prepare, receive, store and submit the required samples for testing by regulatory bodies.
- 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,…..
- Review data required for qualifications and approval of new suppliers.
- Backup person for the QA compliance tasks (Deviation/Change Control/Complaint/Recall/OOS/NCR/CAPA/QRM)
- Update concerned department with any regulatory requirements/Update.
- Coordinate any Conformance / non-conformance to concerned stakeholders
- Prepare reports and minutes for the withdrawal of API and FP to be presented to the EDA inspector
- Distribute status reports and output of EDA regulatory inspection to all relevant departments internally
- Document & archive all the files as per the set procedure.
- Prepare various requests that need to be sent to the Inspection Department of the EDA to obtain certain approvals
- Follow-up of the approval of authority for API and FP.
- Organize and perform own work tasks and assist coordinating activities.
- 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.
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