Manager, Quality & Regulatory Affairs - Seoul, Seoul Capital Area South Korea - 41991

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JOB DESCRIPTION

Job #: 41991
Title: Manager, Quality & Regulatory Affairs
Job Location: Seoul, Seoul Capital Area - South Korea
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Local
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


You will join a fast growing company within the pharmacautical industry, this position will entitle great growth for and with the organization

JOB DESCRIPTION

Responsible of the distribution of the products in the territory. Maintain activity licences necessaries for business. Coordinating customer complaint management with manufacturers quality areas. Support Regulatory activities

  • Implementation and/or maintenance of a quality system in the affiliate. Elaborate and approve relevant SOP.
  • To obtain and keep updated all the licenses necessary for products and distribution activities.
  • To assure distribution activities to be in compliance with regulations and local laws.
  • Act as in country contact person for any customers for quality issues and enquiries and communicate with the manufactures QA Complaint teams.
  • Oversight of the suppliers quality system as indicated in the quality agreement signed by the suppliers
  • Coordinate recall incidents or pharmacovigilance or  medical devices issues. 
  • Record and manage deviation, complaints, CAPAS and change Control.
  • Attend internal and external audits including government inspections and the customers visits
  • To be responsible of distribution activities (own or subcontracted) such as storage, shipping and transport, complaint management.
  • Review of publicity messages and promotional material from a local regulatory perspective.
  • Regulatory local contact person with local authorities and Headquarters.
  • Medical information, to oversee the provision of accurate, relevant, timely information to internal and

QUALIFICATIONS

Degree in Pharmacy

Education:
University - Bachelor's Degree/3-4 Year Degree