Job Description

Job purpose:

The Quality Management Manager is responsible for planning and executing all internal auditing to ensure compliance to ISO, GMP and other required standard system. Included within this activity are the management of the CAPA process, internal auditing, site document control processes and the coordination of all customer complaint investigation reports.

This position is also responsible for analyzing production and transactional processes to identify the cause of problems using problem-solving methodologies, and then working to create and implement solutions. In order to sustain continuous improvement efforts many of the control actions need to be incorporated into our Quality System.

 The incumbent will act as the lead ISO auditor in the facility, providing training and direction to various internal organizations regarding auditing and compliance.

Detailed tasks and activities:

•  Manages, implements and administers Quality Performance activities.
•  Largely involved in formulating Quality Performance development plans, guidelines, policies and short-term strategies as well as setting goals and targets.
• Ensure that the requirements of ISO,J-GMP, GMP, GSP. GLP as well as legal requirements are well implemented and maintained
• Oversees the maintenance and administration of Quality Performance programs, standards and guidelines and constantly explores means of improving on services and processes / procedures.
• Assist the General Director and Plant Managers in orientating employees towards Company quality goals
• Ensure that the company audit programs are developed and executed effectively
• Handles complaints system from clients and product regulatory affair processes
• Supports manufacturing plants & other functional departments in related activities within the scope of responsibilities.
• Acts as drug safety officer for the company
• Supervise, coach, be responsible for performance and career development guidance to team members.
• All other tasks as assigned by the Direct Manager from time to time.