Title:  Executive Quality Assurance

Working location: West Region (Jalan Buroh)

Two-way company transport provided at multiple MRT stations

• Responsible for Quality Documentation (QD) section.

• Assist in Quality audits, certifications, and other quality management

• Main document controller for QA department.

• Handle change control management.

• Update training plan QA department and ensure the plan is followed

• Compile monthly Quality KPIs report.

• Perform quality review / trending for CAPA/ complaint/ change control etc.

Job Responsibilities

Quality Documentation practice (60%)

• To ensure QMS documents for QA department are updated and reviewed as per individual review date.

• To update and maintain QMS document masterlists / schedules.

• To Updated schedules / authorized personnel name lists / emergency contact list etc.

• Oversee other departmental document controllers to ensure they adhere to document control SOPs.

• To ensure regional QMS documents are adopted locally by respective process owner, when necessary.

Training Plan (20%)

• To maintain and update training plan for QA department.

• To maintain and update training record for QA department.

• To ensure QA team adhere to training plan.

Quality Documentation practice (10% )             

• Compile monthly Quality Department related reports

• Assist in training management, to conduct training for QA SOPs / quality-related process such as GxP requirements and to verify warehouse conduct training as per training schedule. (Deviation report will be issued if found non-compliance).

Assistance in other QA-Related tasks (10%)

• Back up PIC of Quality Compliance in the absence of PIC

• Assist in tasks assigned by management when required.

Functional Skills & Knowledge

• Knowledge in ISO 9001/13485 standards

• Knowledge in GxP requirements (x – storage, manufacturing, distribution)

• Strong data analysis skills, management and reporting skills

• Problem-solving skills

Education & Work Experience

• Bachelor's degree in Quality or Science

• Minimum of 3 years of working experience in quality assurance fields or equivalent fields

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