QA & QC Lead: Root-Cause & GMP Excellence

MH Multipack Sdn. Bhd.; Simpang Ampat; On-site; MYR 70,000 - 110,000; Full time

Job summary

MH Multipack Sdn. Bhd. in Penang invites an experienced QA/QC leader to head the Quality Assurance and Quality Control Department.

You will oversee NCR processes, root cause analysis, and preventive actions with real-time dashboard reporting, and you will run internal FAT testing and report against test protocols. You will prepare GMP documentation including User Manuals, IQ/OQ, and ISO records; design FAT protocols to test machinery performance; conduct customer FATs until actions close; and

Qualifications

• Bachelor's degree in engineering or related discipline.
• Minimum 4 years in a quality control or quality assurance role within manufacturing.
• Strong analytical and problem-solving skills.
• Able to work independently as well as in a team.
• Good communication and teamwork skills to collaborate across functions.

Responsibilities

• Lead and manage Quality Assurance and Quality Control Department.
• Execute NCR process including root cause analysis and preventive action with real time reporting dashboard by software tool.
• Execute the Internal FAT and reporting base on test protocol designed.
• Prepare technical GMP documentation (User Manual, IQ, OQ protocol and maintain ISO documentation).
• Design and execute Internal FAT protocol to challenge the machine performance.
• Conduct and execute customer FAT until closing any action items.
• Improve product quality through root cause analysis and preventive action plan with real time reporting dashboard tool.
• Perform quality inspections and ensure products comply with customer specifications and internal quality standards.
• Maintain effectiveness of ISO9001:2015 and ISO 14001:2015 standard requirements and documents updates.

Skills

RCA

7 QC tools

Analytical skills

Team leadership

Communication

Education

Bachelor's Degree in Engineering

Job description

MH Multipack Sdn. Bhd. in Penang invites an experienced QA/QC leader to head the Quality Assurance and Quality Control Department.

You will oversee NCR processes, root cause analysis, and preventive actions with real-time dashboard reporting, and you will run internal FAT testing and report against test protocols. You will prepare GMP documentation including User Manuals, IQ/OQ, and ISO records; design FAT protocols to test machinery performance; conduct customer FATs until actions close; and