Career Category

Job Description

Quality System

CQS shall ensure that quality system  is implemented and maintained to ensure:

• Medicinal products are procured, held, supplied or exported in a way that is compliant with the requirements of GDP;
• Management responsibilities are clearly specified;
• Products are delivered to the right recipients within a satisfactory time period;
• Records are made contemporaneously;
• Deviations from established procedures are documented and investigated;
• Appropriate corrective and preventive actions are taken to correct deviations and prevent them in line with the principles of quality risk management.

Quality Management

CQS shall ensure that management reviews the quality system on a periodic basis. The review should include:

• measurement of the achievement of quality system objectives;
• assessment of performance indicators;
• new regulations, guidance and quality issues that can impact the quality management system;
• improvements that might enhance the quality system;
• changes in business environment.

Personnel

CQS ensures that:

• an organisational chart is available and written job descriptions, along with any arrangements for deputizing are set out for key positions.

Training

CQS need to provide initial and continuous training to personnel who:

• Interacts with customers. This training need to cover at least: on how to recognize and report product complaints and brand protection issues;
• Performs GDP activities.

Documentation

CQS shall focus on:

• the accuracy and quality of local procedures
• appropriate storage of records
• maintaining comprehensive written procedures that are understood and followed
• ensuring procedures are periodically reviewed and version controlled

Operations

CQS is required to:

• provide oversight for all aspects related to in-country product distribution and storage;
• perform a periodic check to ensure that customers are entitle to receive medicinal product
• set-up & maintain Quality agreements with distributors/wholesaler/Logistic Service Providers;
• provide oversight to quality related tasks at Logistic Service Providers;
• host - along with the Responsible Person (RP) - Corporate Quality Audits and Health Authority inspections at the affiliate