- Maintaining professional competence in a wide range of technical, scientific and regulatory fields while promoting excellent working relationships with other departments including the Management Team. The incumbent is expected to operate with a heavy reliance on personal experience, knowledge and skills while always following and promoting the company Core Values.
- Being hands-on technical expertise in resolving issues and identifying risks. This may include recommendations as to appropriate actions and evaluations of resources required.
- Handling the development of staff and overall organization is a vital aspect of this position. Methodologies such as career development plans/actions, empowerment, diversity practices, teamwork, coaching and training must be utilized.
- Maintaining and developing the QMS program to be compliance with ISO9001:2015 requirements including full support to internal auditors to be successful while conducting the internal audit.
- Leading the team during the qualification and validation of products, process and material to ensure that they are in good condition and stable trend before releasing to production.
- Ensuring that tests and procedures are properly understood, carried out and evaluated and assessing product specifications of the company and compare with customer requirements.
- Coordinating with the production department and related sections in the resolution of quality problems and in analyzing these problems for continuous improvement.
- Flow down global information to staff and liaising with customers and other external support and ensuring the execution of corrective action in compliance with customers and company specifications.
- Handling the product & process quality with the strategy of continuous improvement for the day-to-day responsibilities of QC Inspection, labs to ensure support of the Operations.
- Supporting the implementation of Operational Excellence, Lean Six Sigma, 5S and all related activities.
- Ensuring that within the Quality Operations area the QMS is followed and Standard Work is implemented and maintained and follows all Quality System requirements.
- Setting the performance objectives for the team to be a part of the progress team in each workshop and fully support to continuous improvement program which is can improve customer satisfaction and overall performance of the organization.
- Being responsible for the regulatory and good manufacturing practice compliance as outlined in the Quality Manual, Policies and Procedures.
- Managing the total supplier quality process including supplier approval and inspection of incoming raw materials.
- Being responsible for monitoring and evaluating direct reports for compliance with workplace safety and environment policy.
- Managing related audits and ensure compliance with government institutions.
- Bachelor’s Degree or higher in Chemical, Physical sciences, Engineering, or related field
- At least 15 years' experience in quality management jobs, especially works relating to the quality system and 10 years in supervisory level.
- TOEIC score above 700.
- A comprehensive understanding of quality system requirements and processes, within manufacturing operations, is required.
- Knowledge and experience of GMP, FDA, ISO13485 standard; capable of managing a Cluster Microbiologist team and Quality Service team.
- Good interpersonal and communication skills.
- Very good English communication skills (reading, writing, and speaking).
- Must be comfortable in a customer-facing role, understanding the need for being diplomatic but assertive.
- Willing and capable to work with cross-functional teams.
- Good leadership skill.
Our client offers a basic salary, allowance, provident fund, group insurance, a fixed and variable bonus, and a five-day working week.
Reference Code: HQ1101206