QA Specialist - Daejeon

Job summary

Prepare for customer audits, respond to inspections, and establish Corrective and Preventive Actions (CAPA) to ensure compliance with all regulatory and corporate requirements.

Responsibilities

• Prepare for customer audits by ensuring all necessary documentation and processes are in place for successful inspections.
• Prepare the response to customer inspections and certificate audit for ISO 9001/Rx360/EXCiPACT ensuring that all findings are addressed promptly and effectively.
• Coordinate and progress check for Corrective and Preventive Actions (CAPA) in response to audit findings and inspection observations.
• Maintain Standard Operating Procedures (SOPs) and document archiving in compliance with company quality requirements and applicable regulations.
• Manage electronic Quality Assurance (eQA) systems, including the Documentation System, Training System, and QMS, ensuring compliance with all regulatory and corporate requirements.
• Support key quality assurance activities at the site, including Supplier Management, Documentation, GMP training, Change Control, Deviation, Quality Risk Management, Internal Audits, and External Audits.

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