[Company / Industry] Global healthcare logistics company / Supply and Logistics
[Position] Quality Assurance Manager
[Reporting Line] Regional Quality Director
[Employment Type] Permanent
[Location] Seoul, Korea
[Consultant in charge] Simon S. Kim
Reputable global company specializing in logistics for clinical trial materials and sensitive drug shipments.
Implement, communicate and maintain Company’s quality systems and policies at the Seoul, Korea facility, in compliance with the Company's Global quality management system requirements.
Effectively interact with other depot Quality managers, Operations/depot managers and stakeholders to maintain quality and help introduce new quality improvements.
Agree standards and define quality processes and procedures through effective controlled document issue and management.
Liaise with clients on QA/GMP related matters.
Write quality assurance procedures as required for GMP Compliance for Seoul, Korea CTD facility.
Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated corrective and preventative actions (CAPA).
Prepare an external audit program and perform audits of external service providers as part of the vendor selection process.
Host client audits and regulatory inspections and manage the audit report responses.
Manage CAPA plans, collate CAPA data, and identify and implement quality improvement initiatives.
Ensure the local implementation of Client Technical (Quality) and Service Level Agreements.
Identify relevant GMP / quality related training needs and deliver training where required.
Perform a review and release of incoming material receipts in accordance with product specifications.
Perform QA role in qualification/validation activities.
Manage the change control system for Seoul, Korea.
Co-ordinate any product recall as required and ensure that a mock recall is carried out on an annual basis.
With support from the depot manager hold a monthly review of Quality at the Seoul, Korea facility including metrics management and provide a report to site and Global Operations management and to Global QA management.
Support the depot manager in carrying out a quarterly review of training for CTD personnel.
Perform all duties required of the registered Pharmacist to ensure regulatory compliance of the Seoul Korea facility and its operations.
In the role of responsible pharmacist, liaise with Korea health authority in relation to regulatory submission and authorization in order to maintain the appropriate/required licenses for the Seoul, Korea depot.
Ensure compliance with national and international standards and legislation
Ensure timely and efficient management of records pertaining to the Quality Assurance Group.
Travel as reasonably requested by the Line Manager for the performance of duties.
Assist in the development of the CTD facility in other countries and to work with regional third party vendors in continuous development and improvements.
Undertake any other reasonable duties at the request of the Line Manager
To adhere to all company Policies at all times.
Comprehensive knowledge of Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice guidelines
Comprehensive Knowledge of local clinical trials regulations
Excellent written and oral communication skills
Good interpersonal skills
Organized, methodical and efficient approach to work.
Proficient use of Microsoft office
Significant experience working in a Quality Assurance role within a GMP/GSP regulated position.
Educated to degree level, preferably with a BSc in pharmacy, chemical pharmaceutical biologist, industrial chemical pharmacist or any profession related to pharmacy
If you are interested, please contact firstname.lastname@example.org +82-10-4118-2178