Dealing with EDA inspector (keeping registered papers for all products and all documents related to MOH).
- Keeping registrated papers for all products and any update requirements.
- Entering database for all rameda products.
- Preparing, reviewing all papers related to raw materials received to the company.
- Reviewing, approving received packaging materials against MOH approved ones.
- Reviewing, approving for lot release of finished products after being sure that all documents needed for release submitted.
- Follow up of the status of all products sent to NODCAR (inspection department) till approval.
- Preparing and Keeping all documents related to EDA inspector visit as (sampling reports for products ,sampling reports of raw materials ,release reports for finished products and for raw materials also any documented observations she done during her visit any conformities received by her any NODCAR letter received by her or nonconformity reports)
- Follow up with QC to full fill NODCAR comments on time.
- Responsible for doing MRB(material review board) and determining committee members and follow up till last decision .
- Responsible for making investigations and follow up of the effectiveness of product external recall process and analyzing the root cause of such process till closure with EDA inspector.
- Perform quality reviews of manufacturer documentation for compliance with stated requirements.
- Solve and communicate problems identified during quality assurance activities related to EDA routine inspection.
- Documents data obtained during quality assurance activities, consistent with company policies and procedures.
- Preparing monthly report submitted to direct manager.
- Ensure compliance with cGMP & EHS standards.
- Ensures that all activities in his unit or section are done according the relevant cGMP and ISO standards (ISO 9001, ISO 14001, and ISO 45001).
