Area Quality Leader
About this position
Responsibilities
• Ensure leading, reviewing, participation and developing risk assessment (Pre and post production period) to appropriate and compliance of quality management system of any changes in the factory.
• Facilitate resolution of quality issue via improvement plan.
• Ensure non-conforming report in Quality one system were captured appropriate action and compliance with quality management system and standard or regulatory requirement.
• Ensure long term preventive action were captured in improvement plan and communicated to support team.
• Responsible to be representative of quality section in the group meeting of daily or weekly or monthly operation meeting.
• Resolving online quality issue regarding to the point of stopping production operation and freezing stock.
• Ensuring quality and production requirement are considered without affected to operation process, quality management system, regulatory or standard requirement till the final product quality & product safety.
• Work under fast moving organization, standardization and improve the QMS to be more robust and compliance to relevant regulatory standards and international standards within specific and limited timeframe.
• Maintain the effectiveness of QMS under the organization having changes all time.
• Follow up of audit findings, change control, CAPA to be closed with appropriate information/action within a timely manner.
Requirements
• Bachelor’s Degree in Engineering / Science based subject or related field.
• Experienced in process inspection, manufacturing, quality auditor with pharmaceutical /medical device background.
• Experience of audits, applied and understanding on the compliance of international standard such as ISO 13485 , ISO 4074 , ISO 14971 , ISO 23409 , ISO/IEC 17025 , GMP or others.
• Experience of laboratory testing of regulated products.
• Good communication skill.