QA Manager
Dallah Pharma
مجموع سنوات الخبرة :16 years, 6 أشهر
1- Documentation Activities: Implementing and maintaining documentation system (SOP’s), Change control, investigation, disposal, recalls, complaints handling.
2- Manufacturing activities: Monitoring all the activities related to the manufacturing process of pharmaceutical products (Including process control during production and packaging processes, analysis of raw and packaging materials and finished product, and final release of products)
3- Auditing Activities: Internal audits, auditing of Dallah Pharma suppliers and monitoring and auditing of Dallah Pharma distributors.
4- Handling of all recall and complaints: Investigation of market complaints and initiating recalls with risk category assessment for recalled product and investigation of product related failures.
5- Change control: Controlling all change processes through change requests, investigation of reasons lead to change and following up the change results.
6- Deviation reports, Out of specification investigation: Investigation of reasons and determining the appropriate CAPA and follow up the execution.
7- Validation and Qualification activities: Monitoring all the activities and processes related to the quality assurance of all pharmaceutical products (Including but not limited to; …Process Validation, Cleaning Validation, Equipment and utilities qualification, HVAC, water treatment validation and monitoring, temperature mapping and WH Validation studies).
8- Warehouse Activities: Monitoring all activities related to warehouse, including (receiving of raw and packaging material, dispensing and dispatching of finished products)
1- Preparation & supervise the execution of the Process validation protocols.
2- Revision of different department equipments qualification protocols.
3- Environmental Monitoring reports/trends review.
4- Follow-up the implementation of Calibration system.
5- Implement the Training system for the team members.
6- Creation and updating of validation SOPs.
7- Supplier Qualification.
1- Preparation of Process validation protocols (Solid, Semi-solid & Liquid) and monitoring its runs.
2- Preparation of Qualification protocols (mainly Performance qualification protocols).
3- Review and implement the Installation qualification and operational qualification with their responsible.
4- Review the utilities qualification protocols which prepared by Engineering department
5- Creation of HVAC & Water system performance qualification protocols
6- Trends preparation for water station and Environmental monitoring results.
1. Executing all manufacturing processes of solid section including kneading (Euro-vent system), powder mixing (Bohle blender), compressing (Killian), coating (ACCELA COTA) and capsule filling (MG2 FRUTURA).
2. Performing of reconciliation and revision of processing batch record after the end of the manufacturing
3. Reporting any deviation may be raised during any manufacturing process to production supervisor.
4. Prepare monthly and annual production report.