Quality Assurance Assistant Manager

JOB SUMMARY

To manage the tasks and activities to ensure all quality systems for medical devices and food safety in operation practices have complied with related standards.

Working location: Khlong Sam Prawet, Lat Krabang, Bangkok

DUTIES AND RESPONSIBILITIES

1. Take care of Quality systems for medical devices and food safety (60%)

Monitor all established and implemented activities regarding quality systems for medical devices and food safety.

Report the result of the quality system for medical devices and food safety performances.

Lead the audit both internal and external of quality systems for medical devices and food safety.

Lead the quality control and releasing process in the co-packing facility.

Establish the quality management system plan and manage to complete all activities.

Ensure temperature monitoring and compliance.

Review and ensure compliance with related laws and regulations.

Take care of calibration, pest control, and cleaning programs whole the assigned site.

Lead all validation and qualification activities.

Coordinate the management review for all systems (quality system for medical devices and food safety)

Oversee the security control performance on the site.

Lead for the risk assessment in terms of quality systems for medical devices and food safety.

Ensure the monitoring and measurement are done as planned e.g., temperature monitoring, water, and wastewater analysis

2. Promote the quality system for medical devices and food safety awareness (20%)

Plan and ensure the communication of the quality system for medical devices and food safety.

awareness via different channels e.g., training, toolbox talk, etc.

Plan and ensure for emergency responses and BCP

3. Follow up of the investigation, corrective action and follow up of NC, CAR/PAR (20%)

Summarize, analyze on issues regarding to quality system for medical devices and food safety e.g., Non-Conformity (NC), CAR/PAR

Follow up on the effectiveness and closure of NC and/or CAR/PAR

KNOWLEDGE AND SKILL REQUIREMENTS

At least 05 years of working experience at QA/Quality Assurance position(s) in medical devices or food manufacturing.

Experience in logistics industry is a big plus.

Knowledge of quality systems for medical devices and food safety and management systems e.g., ISO9001, GHPs, ISO13485, ISO14971, etc.

Native Thais level, fluent English

Skills in management and planning

Experience in the implementation of any international standards

Able to operate SAP system

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R100330