Executive, Quality Assurance

Working location: West Region (Jalan Buroh)

• 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

• 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.

• 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.

• 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).

• Back up PIC of Quality Compliance in the absence of PIC
• Assist in tasks assigned by management when required.

• 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

• Bachelor's degree in Quality or Science
• Minimum of 3 years of working experience in quality assurance fields or equivalent fields