JOB RESPONSIBILITIES
To lead Audit and Inspection activities (internal site, government bodies, third-party regulatory bodies etc.) via proper coordination with auditing groups and inspectors through all audit stages.
In charge of company’s quality compliance programs.
To facilitate preparation, review, approval, and submission of quality-related documentations and systems.
To coordinate Quality meetings, Quality Management Review as well as Improvement Programs development.
To execute and monitor process audit on timely basis and maintain site quality manual.
To implement Site Quality Objective and IMPACD Gap Assessment based on established target.
JOB REQUIREMENT
Bachelor's Degree Holder in Engineering or Science.
At least 5 years working experiences in manufacturing environment, preferably in Medical / Pharmaceutical Industries.
Have proven experience in Internal & External Auditing in manufacturing industry.
Possess strong knowledge in cGMP, ISO 13485, MDSAP as well as regulatory compliances in medical-related industries.
Excellent communication and organisational skills.
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