• Internal Auditing:1- Preparing the internal audit plan at the beginning of the year. 2- Preparing audit checklists using the company’s procedures and ISO 9001:2015, ISO 13485:2016, and ISO 28000:2022 as references. 3- Performing the internal audit and communicating the non-conformities to the department in the agreed time. 4- Following up with CAPA implementation. • CAPA System handling:1- Follow up with all CAPAs initiated from different sources… Show more • Internal Auditing:1- Preparing the internal audit plan at the beginning of the year. 2- Preparing audit checklists using the company’s procedures and ISO 9001:2015, ISO 13485:2016, and ISO 28000:2022 as references. 3- Performing the internal audit and communicating the non-conformities to the department in the agreed time. 4- Following up with CAPA implementation. • CAPA System handling:1- Follow up with all CAPAs initiated from different sources (internal/external audits, deviations, 2- Investigation of all deviation categories using quality tools (6 M, Gap analysis & fishbone diagram).3- Participating with the top management to decide the immediate action in case of critical and major deviations. • Overseeing the Shipment receiving process:1- Revising the shipping documents along with the goods receiving report to make sure all the data is correct.2- Reviewing the Data Loggers extraction for each shipment.3- Communicating any deviation to the supplier. • Change control system handling:1- Decide along with the QA manager if the CCR is approved or rejected.2- Communicate with concerned parties about certain changes to decide the availability of implementing this change.3- Update the monthly tracker to include all CCs, their status & needed actions to be followed up.4- Archiving all the evidence needed to prove the change process. • Customer Satisfaction:1- Sending customer surveys to all concerned parties.2- Communicating with customers via phone or email in case dissatisfaction occurs. • Documentation:- Control of documents throughout their life cycle, including preparation, review, issue, distribution,and revision of all controlled documents. • Final product release on SAP. • Supplier evaluation. • Participating in quarterly management reviews Show less

• Observing the various parts of the factory and insure its compliance with QMS, cGMP & company Health and Safety Policies.•Insuring the compliance of plant conditions like humidity & temperature with set guidelines.•Handling product complaints starting from the origin of the complaint , to documenting the complaint in certain forms ,Then conducting a corrective action suitable for the situation.•Detecting (Alert Limit) for humidity & temperature in various parts of the… Show more • Observing the various parts of the factory and insure its compliance with QMS, cGMP & company Health and Safety Policies.•Insuring the compliance of plant conditions like humidity & temperature with set guidelines.•Handling product complaints starting from the origin of the complaint , to documenting the complaint in certain forms ,Then conducting a corrective action suitable for the situation.•Detecting (Alert Limit) for humidity & temperature in various parts of the factory.•Conducting change control to any change in the process, raw materials, equipment or facilities.•Develop procedures to ensure that Quality System documents are originated, changed, reviewed, distributed, archived andperiodically reviewed using systems that are efficient and meet all regulatory requirements.•Reviewing and approving SOPs and Batch Production/Packaging Records according to (GDP).•Preparing the Annual Product Review (APR) using Microsoft Word & Excel.•Participating in quality audits (self-inspections, internal and external audits & supplier audits).•Attended 3 different Process Validation batches for 3 different products.•Applying six sigma system to minimize the variables in the manufacturing process anddecrease defects..• Insuring that documents in various parts of the company will meet our Key Performance Show less