Manager QA
Jamjoom Pharma
مجموع سنوات الخبرة :17 years, 10 أشهر
- The Company Authorized Person
- Finished goods approval and release for Jamjoom Pharma products and Pfizer toll packaging products.
- Reporting the released products to Saudi FDA importing, batch release and clearance system.
- Review of batch records and analytical test reports.
- Ensure that all necessary checks, sampling and testing have been done before releasing the finished goods.
- Verify that the produced batches meet approved specifications.
- Approval and signing of finished product COA.
- Ensure that all products related change controls are properly evaluated and all necessary actions are completed.
- Ensure that all related deviation and OOS are properly investigated and assigned CAPA are effectively completed.
- Customer Complaint investigation and response.
- Conduct internal audits and distribution chain audit.
- Conduct vendor site audits.
- Conduct GMP training and on job training.
- Writing and updating SOPs.
- The Company Authorized Person
- Finished goods approval and release for Jamjoom Pharma products and Pfizer toll packaging products.
- Reporting the released products to Saudi FDA importing, batch release and clearance system.
- Review of batch records and analytical test reports.
- Ensure that all necessary checks, sampling and testing have been done before releasing the finished goods.
- Verify that the produced batches meet approved specifications.
- Approval and signing of finished product COA.
- Ensure that all products related change controls are properly evaluated and all necessary actions are completed.
- Ensure that all related deviation and OOS are properly investigated and assigned CAPA are effectively completed.
- Customer Complaint investigation and response.
- Conduct internal audits and distribution chain audit.
- Conduct vendor site audits.
- Conduct GMP training and on job training.
- Writing and updating SOPs.
- - Review of batch records documents and analytical test reports.
- Handling of change management system, perform impact analysis and review of change requests before implementation, follow up for action plan implementation and closing of the change.
- Deviation investigation, root cause analysis, CAPA and closing.
- Conduct internal audits and coordinate external audits.
- Annual product review coordination.
- Review results of stability studies.
- Review and approve product specifications and packaging material specifications.
- Control and approval of packaging formula - BOM.
- Market goods return investigation and disposition.
- Coordinates vendor approval program.
- Conduct GMP training and on job training.
- Writing and updating SOPs.
- Monitoring and inspection of manufacturing and packaging process.
- Approval of line clearance and verification of materials and documents.
- Perform in process checks and sampling of finished goods.
- End line verification and batch record audit.
- Ensure the implantation and closing of CAPA.
- Ensure compliance of GMP standards SOPs on production floor.
- Packaging material and container / closure testing and disposition.
- Prepare packaging material specification.
- Review and approve artwork of packaging materials.
- Manage and control of artwork changes for the packaging materials.