Terumo VietNam ★ 4.8

JOB SUMMARY

Being responsible for process quality assurance in TBV and supports Quality Management through advanced level activities requiring broad business knowledge. Driving quality improvements of products and processes, through planning and supervising the in- process controls. This is achieved by architecture / building and verification of new or improved processes, preventing non-conformity and customer complaint and supporting their investigation, training, driving and executing the improvement of manufacturing process and implementation of Quality Systems, Policies, and Procedures. Finally manage the activities to achieve company goals. The person may take a responsibility of improvements projects, CAPA owner, internal audit, and other tasks to achieve the goals.


ESSENTIAL DUTIES AND RESPONSIBILITIES

• Works with quality management, manufacturing, engineering, and other functional groups on regulatory and quality system compliance issues. Develops or participates in the development of solutions to problems of intermediate to high complexity.
• Leadership, collaboration, guidance, and supervision of all In-process quality activities. May plan workloads, allocating tasks and monitoring progress against targets
• Manage team’s scope of work, team development, and monitoring to ensure the co-ordination of proper implementation and handling of operations quality activities.
• Performs varied quality/regulatory activities such as developing and implementing plans and procedures to comply with applicable local and international regulations as well as initiate quality improvements and support quality engineering in investigations, corrective actions, nonconformities etc.
• Interprets, executes, and recommends modifications to operating policies/procedures where appropriate. Modifies, updates, and executes established programs to achieve and maintain a state of compliance.
• Document quality issues, execute root cause investigations and implement actions to address the issues as well as propose, implement and execute corrective and preventive actions under own responsibility, support non-conformities and improvements.
• Supports the implementation and maintenance of the Quality System.
• Provides support to the internal and external audit program.
• Present topics under his/her responsibility to the management as well as train and support team members as well as new associates for their development.