Job Description

Overview:
The primarily role of the Quality System Specialist (Fixed Term 12-months) is to:

• 
  Support ISO 9001:2015 and SS620: 2016 or equivalent for Singapore Distribution Centre (Asia Pacific and South East Asia
• Support internal audits
• Identifies gaps in compliance and takes necessary action(s) to correct
• Utilizes critical thinking and problem solving skills in driving to root cause and corrective action
• Can deviate from procedures based on knowledge of operation.

• Quality Assurance Related Activities
  • Ensures QMS programs meet objectives and complies with all applicable regulations and standards.
  • Perform activities related to nonconformance, corrective actions and effectiveness checks.
  • Works with operations personnel to continually improve quality procedures and methods.
  • May perform activities related to one or more quality assurance functions including label QC activities, assisting with document inquiries and retrieval of archived documents and records, electronic records, SAP transactions related to Quality Notification.
  • Issue corrective action report based on internal/external audit findings.
  • Assisted to communicate controlled documents (SOPs,WIs, Forms) to distribution centre/sales organization.
• Regulatory Related Activities
  • Support reporting of import and export license from Health Science Activities
  • Support ship hold and field safety support activities as required
• Regulatory Surveillance Related Activities
  • Prepares, maintains and updates library or external regulatory standards, reference and guidance documents.
• Any other general regulatory and quality activities or project been assigned by the supervisor.

• Diploma or Bachelor’s degree or equivalent in Biology, Chemistry, Medical Technology, or related field
• 1-2 years related experience or equivalent combination of education and experience
• Basic analytical, communication, problem solving, critical thinking, and computer skills
• Working knowledge of policies, practices and procedures relating to Quality Assurance
• Uses tact and cooperative relationships