QHSE Officer

Position Overview

The QHSE Officer assists the QHSE Manager in coordinating the activities required to meet the quality standards. The assistant helps in monitoring and advising on the performance of the quality management system, produce data and report on performance, measuring against set standards.

Key Duties and Responsibilities:Quality Assurance

Ensure the proper organization of studies according to the internal procedures, Good Clinical Practices, International and local legislation.Setting up and maintaining the QA system according to GDP and ISO 90001.Implement CIDP 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 Suppliers audits, study audits and internal audits.Organizing the Management Review Meeting with the help of the QHSE Manager & Global QHSE Manager

Quality Control

Verification of the study protocol documents and study file before the study beginning.Quality Control on study Documents.Verification of preliminary results and study reports.QC Support for the CIDP Group

Health and Safety

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

Environment

In charge of monitoring environmental measures.Should raise staff awareness regarding environmental issues.Other QHSE related duties, responsibilities & functions.

Trainings

Assist the training responsible for the management of training.

Other Skill/Abilities

Have a flexible attitude.Good communication skills.Self-motivated and able to work with minimal supervision.Have a highly energetic, flexible, and driven personality.Be able to adapt quickly in a rapidly changing environment.Proficient in MS excel,word & ppt.