a. Quality Assurance

- Ensure the proper organization of studies according to the internal procedures, Good Clinical Practices, International and local legislations.

- Setting up and maintaining of the QA system according to GCP and ISO 9001.

- Implement Quality, Ethics, Labour and Environment Policy.

- Participate in the writing, update and follow-up of quality documents.

- Determination of Quality Objectives.

- Setting up of correction & CAR (Corrective Action and Root cause analysis).

- Carry out internal audits and the writing of internal audit reports.

- Follow up the NC dashboards.

- Follow up client's requests/demands and client's satisfaction.

- Conduct Supplier audits, study audits and internal audits.

- Organizing the Management Review Meeting with the help of the QHSE Manager & Global QHSE Manager.

b. Quality Control

- Verification of study protocol, study documents and study file before the study beginning.

- Quality Control on study Documents.

- Verification of preliminary results and study reports.

- QC Support for the Group

c. Health and Safety

- Participates in the implementation of actions following job risk analysis.

- Ensures that protective equipment is available to staff.

- Performs post-incident investigations and communicates with the QHSE Manager and the MD until closure of corrective actions.

- Monitoring health & safety measures.

d. Environment

- In charge of monitoring environmental measures.

- Should raise staff awareness regarding environmental issues.

- Other QHSE related duties, responsibilities & functions.

e. Trainings

- Assist the training responsible for the management of training.