Quality Assurance Manager, South Korea/APAC
Veröffentlicht:
30 Oktober 2024Pensum:
100%- Arbeitsort:APAC, Korea, Seoul, CSL Behring
Development and maintenance of quality operations which include (but is not limited to):
• Quality responsibility for all CSLB products licensed, marketed or supplied within Territory of responsibility.
• Compliance with local as well as international regulations (e.g. GDP) and inspection readiness.
• Obtain / oversee the legal documentation required for pharma license into the Territory.
• Maintains up-to-date Quality Agreements.
• Develops, implements and maintains local Quality procedural documentation (in accordance with Global policies and procedures and the local document management system, if required).
• Monitors performance indicators (KPIs) related to quality compliance.
• Resolves quality-related issues.
• Archives and maintains all quality documents in line with CSLB procedures and legal requirements.
Implementation and maintenance of Quality Management System in compliance with local regulations and CSLB standards, including but not limited to:
• Deviation Management
• Corrective Action Preventative Action (CAPA) Management
• Technical Product Complaints Management
• Change Control Management
• Documentation Management
• Training Management
• Recall Management
• Self-Inspection Management
• Quality policy
• Quality Risk Management
• And recommendation for improvements to the quality system supporting CSLB business in the country
Quality Control Testing and Batch Release
• Manage National Assays / local QC testing in accordance to MFDS requirements
• Make batch disposition decision and perform release in relevant system
Deviations and Corrective and Preventive Actions (CAPA) Management
• Ensures deviations are timely reported, investigated, managed and closed in relevant system according to CSL procedures.
• Oversees the affiliate / region CAPA process and ensures CAPA are implemented, followed-up and closed in a timely manner in relevant system.
Product Complaints Management
Ensures relevant Product Complaints are timely reported, investigated, managed and closed.
Training Management
• Ensures systems for initial and continuous training plans are implemented and maintained for all personnel concerned, according to training plans and regulations.
• Ensures GDP Training is provided to the relevant personnel (if applicable) and ensures the relevant affiliate personnel is aware of the QA responsibilities (eg. product identification, suspected falsified medicines, Complaints, deviations etc).
• Oversees CSL Learning Management System.
Self-inspections & Quality Audits Management
• Ensures that self-inspections of the affiliate / regional operations and quality system are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Supports and participates in corporate organization audits and assists in audit preparation activities, including the development of CAPA plans and the close out of any audit action items.
Change Control Management
• Ensures that an effective local change control process is implemented and compliantly managed within the affiliate.
• Oversees the affiliate Change Control process and ensures change requests are implemented, followed-up and closed in a timely manner.
Risk Management
• Performs activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks identified.
• Manages the review and implementation of Quality Improvement/remediation plans for the Affiliate to ensure compliance and inspection readiness.
Quality Queries Management
• Manages quality queries received from customers
Product Recalls & Field actions Management
• Acts as Recall Coordinator and promptly performs any recall operations for medicinal products from the market according to global quality procedures.
• Co-operates with marketing authorisation holders and national competent authorities in the event of recalls.
• Provides assistance as required in the event of a field action, as determined by the Recall Team.
Product Returns Management
• Ensures product returns are managed efficiently.
• Decides on the final disposition of returned products.
• Approves any returns to saleable stock where acceptable according to company and local regulatory policy.
Importation and Supply of Unlicensed Products
• Ensures that any additional requirements imposed on certain products by national / regional law are adhered to e.g. specials, unlicensed imports.
Regulatory reporting and Quality Intelligence
• Acts as primary contact point to report any non-conformance delivered to the Affiliate as not meeting the requested quality criteria.
• Ensures local regulatory information related to quality topics and assess impact for CSLB activities.
Local Health Authority Inspections
• Host the Health Authority where applicable for routine inspection
Support CSL overseas manufacturing sites with MFDS inspections
Our Benefits
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
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As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
