Quality Assurance Manager

[Company / Industry] Global healthcare logistics company / Supply and Logistics

[Position] Quality Assurance Manager

[Function] Operations

[Reporting Line] Regional Quality Director

[Employment Type] Permanent

[Compensation] TBD

[Location] Seoul, Korea

[Consultant in charge] Simon S. Kim

Company Description:

Reputable global company specializing in logistics for clinical trial materials and sensitive drug shipments.

Job Description

• 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.

[General]

• 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.

Job Requirements

• 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

• Fluent English

• 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 simon.kim@rp4rp.com +82-10-4118-2178