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    Simon S. Kim
    Nov 05, 2019
      ·  Edited: Nov 06, 2019

    Quality Assurance Manager

    in Current Job Openings

    [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

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