Officer –Quality Assurance - บริษัท ดีซีเอช ออริกา (ประเทศไทย) จำกัด

Primary Purpose and Function

To support and maintain the Quality Management System (QMS) in compliance with ISO 9001, ISO 13485, GMP, GDP, applicable regulatory requirements, and customer expectations, ensuring effective quality processes, regulatory compliance, and continuous improvement within DCH Auriga Healthcare Business Unit.

KEY RESPONSIBILITIES

• Implement, maintain, and continuously improve the Quality Management System (QMS) in accordance with ISO 9001, ISO 13485, GMP, GDP, applicable regulatory requirements, and customer requirements.
• Perform product inspection activities and review related records to verify product status for product release, returns, and quality-related issues in accordance with approved procedures and work instructions.
• Plan, coordinate, and conduct internal audit activities to ensure compliance with established quality standards, internal procedures, and annual audit plans.
• Monitor and follow up Corrective and Preventive Actions (CAPA) to ensure timely implementation, closure, and effectiveness verification.
• Analyze quality trends and performance data to identify recurring issues, improvement opportunities, and potential risks requiring corrective actions.
• Prepare and analyze quality performance metrics, including audit findings, CAPA status, complaints, non-conformities, and change control trends for Management Review meetings.
• Coordinate and support customer audits, supplier audits, and regulatory inspections, including preparation of required documentation and follow-up activities.
• Verify pest control activities and review service reports to ensure compliance with approved service plans and facility requirements.
• Establish and maintain calibration programs and verify calibration activities and certificates for measuring and monitoring equipment.
• Develop and execute validation and qualification plans, protocols, and reports in accordance with approved schedules and procedures.
• Maintain document control processes to ensure all quality documents are reviewed, approved, distributed, revised, and archived in accordance with company procedures and customer requirements.
• Participate in risk management activities, change control processes, and continuous improvement initiatives.
• Perform any other duties and responsibilities as assigned by the Quality Manager.

Duties and Responsibilities

• Develop, implement, and maintain Quality Assurance and Quality Control activities for warehouse and distribution operations, including investigation and resolution of non-conformities (NCs), deviations, and customer complaints.   
• Plan, coordinate, and support internal audits, customer audits, supplier audits, and regulatory inspections. Monitor and follow up CAPA implementation to ensure timely closure and effectiveness.
• Manage and maintain quality system programs, including Change Control, Temperature Mapping, Equipment Calibration, Pest Control, Document Control, Validation & Qualification, and Quality.
• Consolidate, analyze, and report quality performance data, including audit findings, CAPA status, complaints, non-conformities, and quality metrics for Quality Meetings and Management Review. Support customer requests related to quality documentation and compliance requirements.
•  Perform other quality-related duties and projects as assigned to support Quality Objectives, Key Performance Indicators (KPIs), business continuity, and continuous improvement initiatives.

• Bachelor's Degree in Pharmacy or Science or related field. Equivalent experience in Quality Assurance may be considered.
• Minimum 3 years of experience in Quality Assurance, Quality Systems, or related technical functions within pharmaceutical, medical device, healthcare, manufacturing, or logistics industries.
• Experience in pharmaceutical, medical device, healthcare, or other regulated industries is preferred.
• Knowledge of Quality Management Systems and applicable standards, including ISO 9001, ISO 13485, GMP, and GDP requirements.
• MS Offices skill in Word, Excel, and PowerPoint / IT skill.
• Prioritize and accuracy of work.
• Documentation arrangement skill.
• Team work skill, Multi functional collaboration skill.
• Result oriented and Quality mind.