【職務概要】
Engineering Manager is responsible for the management of Engineering Group.

In order to keep the continual supply of high-quality finished products to the Japanese market, which meet the respective regulatory requirement, this position is accountable for supervising the control over maintenance, validation and environmental control, utilizing sufficient knowledge and experience for GMP issues. They’re also responsible for talent development.

【職務内容】
Responsible and owns of engineering documents, training, and activities.

Plans for technical GMP improvement to be conducted at Engineering, and control and check the implementation.

In case of technical issues such as deviations and change proposals in packaging area, technically control the process to assure the quality.

Develop local processes and procedures in accordance with Engineering management system.

Provides technical oversight and stewardship for the production operations,

Ensures staff are qualified and that the required initial and continuing training of technical support personnel is carried out and adapted, according to need, to ensure appropriate operations support.

Ensures the process and product are well characterized and that the process description and control strategy, including the measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications) have been documented in a process flow document (PFD) or its equivalent.

Ensures that the processes, facilities, equipment, or systems for which they are responsible have been validated or qualified, and

Ensures that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.