Consultant

• Jan 2023 - Present

Quality & Regulatory Affairs Engineer

• Sep 2022 - Dec 2022

- Project manager of the internal audit in compliance with ISO13485:2016- Deployment of the Quality Management System including the implementation of identified corrective actions following the internal audit- Preparing external audits and verifying the implementation of the recommendations that emerge- Initiating the preparation of the CE marking technical file

Quality & Regulatory Affairs Engineer

• Mar 2022 - Aug 2022

- Maintaining and improving the existing supports and tools of the ISO 13485 Quality Management System in preparation for FDA and CE marking approvals- Proposing new Processes & Procedures in compliance with ISO 13485: 2016 standard, EU 2017/745 & 21 CFR 820 regulations- Preparing Key Performance Indicators dashboard with concerned departments- Preparing & conducting internal audit

Senior Quality Assurance Officer

• Jun 2019 - Aug 2021

-Developing, Implementing, reviewing and maintaining SOPs, policies, templates and other documentation for all Quality assurance activities.-Developing schedules for the periodic review of programs and taking the lead in tracking processes subject to review and evaluate the effectiveness of corrective and preventive action plan.-Overseeing and coordinating the investigation of customer complaints and non-conformities.-Working with other departments to assure timely completion of CAPA’s, change control and ensure that KPI’s are met.-Delivering trainings in quality and health related topics to personnel including trainings on procedures and working instructions.-Conducting risk assessment studies for quality and other departments.-Preparing and participating in all external audits.-Acting as a principal project lead for new and existing quality projects as well as providing continuous guidance and support.-Improving operating procedures by developing and driving continuous improvement initiatives.-Team leader of all conducted internal quality audits and inspections.-Investigating deviation and incidence of staff non-compliance with procedure.-Reviewing, negotiating and approving quality agreements and any other related quality document to assure their coherence within the implemented quality system.

Quality Assurance Officer

• Oct 2015 - Jun 2019

-Developed, updated and maintained quality assurance policies and procedures as per ISO9001:2015 and GSDP.-Team Leader of the Good Storage and Distribution Practices Project.-Investigated all non-conformities and customer complaints.-Conducted Internal Audits, evaluated findings, identified areas for potential improvement and initiated corrective actions. -Performed training to all employees on Good Storage and Distribution practices, ISO 9001, quality related topics and new procedures.-Participated in external audits, prepared and followed up on action plan implementation.-Developed, recommended and monitored CAPAs, KPIs, change control and risk assessment.-Handled assessment and gap analysis of newly established quality projects.-Organized customer satisfaction surveys, analyzed data and reported results to management.-Prepared and organized management review meetings.

Infection Control & Occupational health and safety assistant

• Sep 2013 - Sep 2015

-Implemented techniques for prevention of nosocomial infections, including routine surveillance, visiting locations and reporting cases to direct manager for actions and review. -Participated in internal audits to verify proper implementation of policies, procedures and recommendations related to aseptic techniques, hospital cleanliness, environment and sanitation, waste management, isolation protocols or else. -Participated in investigating clusters of infections and outbreaks; took cultures and samples from various locations in the hospital, and followed up on analysis and results -Participated in developing effectual policies and procedures for the department and hospital that ensure compliance with international standards and CDC (Centers for Disease Control and prevention). -Participated in preparing and conducting orientation, training, education and awareness campaigns and programs on infection prevention and employee’s safety. -Collected data, filled related forms and prepared routine reports and statistics to be submitted to direct manager. -Participated in ensuring proper application of procedures and protocols related to staff safety to identify and assess various hazards and related categories -Participated in carrying out internal audits to ensure proper application of measures, standards and recommendations and to detect sources of safety risks, hazards or non-compliance, and implemented appropriate control measures. -Ensured the proper use of PPEs according to regulations. -Assisted with the investigation of accidents and unsafe working conditions, studied possible causes and recommended remedial action. -Participated in developing occupational health and safety systems including policies, procedures and manuals based on OHSAS 18001.

Internship

• Mar 2013 - Jun 2013

Implementing a quality management system for the laboratory according to ISO 15189 and ISO 17025 Implementing a quality management system for the laboratory according to ISO 15189 and ISO 17025

Internship

• Jul 2012 - Jul 2012

Quality Control lab Quality Control lab

Student Internship

• Feb 2012 - Feb 2012

chemistry and microbiology lab chemistry and microbiology lab