Dina Atalla

1. Follow all aspects related and trending of out-of-specification results, failure investigation, non- conformance, deviations, change controls, and complaints for Toll manufacture. 2. Follow and handling EDA requirements for release raw materials and finished products or any requirements. 3. Handling IDA requirements for license any new line or new product. 4. Internal audit. 5. Issuing the master document Batch record and SOPs. 6. Develop and ensure implement annual calibration plan 7. Toll manufactured Coordinator 8. Perform Annual product quality review.

1. Follow GMP compliance of activities done. 2. Control of good documentation practice. 3. Responsible for tracking and trending of out-of-specification results, failure investigation, non-conformance, deviations, change controls, and complaints. 4. Annual product quality review. 5. In-process control in Filling and Packaging department.

1- Follow GMP compliance of activities done in all departments. 2- Issue BOM and distribution it to departments involved. 3- Reviewing batch record for completeness, correctness, compliance of in-process control results with specification and reporting of unusual incidents. 4- Investigation of any deviations and follow up of it's CAPA. 5- follow changes control system in the area responsibility. 6- Issue SOPs of QA department and file all master SOPs of all departments, follow it's update. 7- Control of good documentation practise. 8- Preparing key documents such as validation master plan and prepare process validation protocol and report. 9- Issue performance qualification protocol and report (HVAC and water station) 10- Performing annual product quality review. 11- Make all activities for internal audit (SOP, plan,......), make sure that audits are performed and follow up of audit reports and it's CAPA. 12- In-process control in production: *Making sure that production facilities are clean and, when appropriate, disinfected. *Making sure that the necessary calibration are performed and records kept. *Making sure that the premises and equipment are maintained and records kept. *Making sure all procedures done according to batch manfuctier record. *Making sure implementation all GMP. *Sampling intermediate and finished sample.