Overview

• Salary

  5,000 MYR ~ 6,500 MYR

• Industry

  Manufacturing(Electronics/Semiconductors), Manufacturing(Machinery), Manufacturing(Chemicals/Materials), Manufacturing(Pharmaceutical/Medical Equipment)

• Job Description

  Responsibilities:
  - Responsible for reviewing and maintaining validation & verification activities to ensure manufacturing processes, equipment, software systems, test methods, and facilities comply with applicable regulatory requirements, Quality Management System (QMS) standards, and applicable global medical device regulations.
  - Participate in new project introduction and project transfer qualification activities, such as lead on qualification and validation strategies.
  - Coordinate validation activities for software used in production, quality, and manufacturing processes where appropriate.
  - Ensure validation and verification documentation is accurate and meet applicable regulatory expectations.
  - Perform periodic review and revalidation activities as required.
  - Coordinate and support investigations involving nonconformances, customer complaints and/or audit findings related to validation. Follow-up on the corrective and improvement actions as required.
  - Support measurement system verification activities, including Gauge R&R and measurement system analysis (MSA).
  - Provide training to quality technicians, inspectors or relevant personnel on validation requirements and best practices when necessary.
  - Other responsibilities are subject to the arrangement of the immediate superior/management.
  
  Authority:
  - Make the decision on validation & verification acceptance criteria.
  - To stop production or shipment when nonconformance is found due to not meeting validation and/or verification requirements.