Roles & Responsibilities

QMS Management: 

-         Establish quality master plan and implement quality management system in compliance with local regulations/guidelines and company procedures, including document management.

-         Manage non-conformances, root cause investigations and propose corrective and preventive actions.

-         Conduct Product Quality Review, where required.

-         Responsible to manage change controls and coordinate annual management review.

-         Manage local suppliers/vendors, including routine oversight of DC quality operations.

-         Review documents and ensure the process and procedure are well documented and executed under data integrity.

-         Provide necessary trainings to the office staff and staff of the distribution center to improve quality standards.

Regulatory Compliance

-         Maintain all quality documentation such as product master file and standard operation procedures in accordance with local regulations and registered details.

-         Review and approve artworks and labelling materials.

-          Prepare and manage regulatory inspections by MFDS and regional audit by regional quality group.

Product Release

Complaint Handling & Recall

Requirements

A minimum of Bachelor’s degree in pharmacy, chemistry or biology is required.

Pharmacist license is required.

A minimum of 3 years of working experience in the quality affairs of pharmaceutical or medical device industry is required.

   담당자: 김대식
   연락처: 02-6925-5391
   이메일: ds@hrfind.co.kr