Quality Assurance Manager
- Seoul, South Korea
- Department: Quality
- Region: APAC
You will be responsible for Quality Assurance responsible for South Korea. Responsible for QA import process in South Korea. You will be responsible for compliance with the technical and regulatory requirements related to the quality of the finished products and the approval for the release of such products for sale.
1. Responsibility for the Release process where required
- Review QP release documentation, shipping conditions and expiry date are in compliance with the regulatory national requirements and, consequently, perform local release of every import, where required.
- Responsible Person signing off on release documentation.
- Responsible for communication with a local distributor
2. Oversees Local Quality Management System consistent with in-country requirements and Biogen QMS
- Oversees the documentation management system for local GDP procedures
- Leads and coordinates Quality Management Reviews
- Leads implementation and alignment of Global Quality Management Systems (Global Directives)
- Oversees affiliate’s training program as Functional Learning Liaison
- Responsible for the local management of Deviations, CAPAs, Change Control as initiator, investigator or QA
- Responsible for the affiliates Quality Risk Management System as identifying potential risk, assessment and its escalation.
3. Responsible for the maintenance of distribution applicable licenses
- Ensures that affiliate’s personnel and processes meet applicable requirements and maintains licenses and certificates
- Ensures that Biogen products are handled in accordance with applicable licenses and requirements
- Is up-to-date with cGDP and applicable regulatory requirements
- Ensures that suppliers are approved in coordination with responsible departments. Reviews customer entitlement on an annual basis. Approves any subcontracted activities which may impact on GDP
- Responsible for the disposition of product returns, rejected and potentially falsified medicinal products
- Oversees distribution related complaints and deviations
- Is the point of reference to management and employees for all matters relating to GDP, and QA oversight of product distribution.
4. GxP-related Audits and Inspections:
- Accountable for GDP inspections with preparation readiness, coordination, hosting and required follow-up and CAPA implementation
- Supports health authority Inspections with preparation readiness and coordination.
- Hosts Affiliate Audits and coordinates related follow up and CAPA implementation
- Leads and coordinates self-inspection program
- Provides oversight of vendor management (affiliate external partners who perform GxP activities) including quality agreement maintenance
5. Product related issues:
- Participates in Distributed Material Review Boards and Recall Committees related product distributed in China and Taiwan as Responsible Person.
- Responsible for the coordination of local Product Recalls and mock recall exercises. Co-responsible for recall reconciliation and effectiveness checks
- Oversees handling of Technical Product Complaint processes, supports related investigations and follow up as necessary
- Ensures that suspected falsified product is immediately notified for investigation and coordinates local management as per Biogen procedures, assures that suspected falsified product under Biogen control is put on hold
- Accountable for all communication with the Competent Authorities relating to product quality and ensure that the review of this communication is appropriate and approved
- Oversees temperature excursion assessments
6. Quality Assurance regional activities support to Taiwan, China and Hong Kong
- Support set up of cluster affiliates with QA activities such as training, Technical Product Complaints
Minimum Experience Requirements:
- Experience PR in south Korea from biotech or pharmaceutical industry
- Proven knowledge of regulations in south Korea (Korean Pharmaceutical Affairs Act)
- Knowledge of and experience with the current Good Distribution Practice and importing processes.
- Experience with development and maintenance of quality management systems
Minimum Education Requirements:
- Degree in Pharmacy (or equivalent)
- Korea Pharmacist License