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Job Post Details

Quality Assurance Specialist - job post

Guerbet
134개의 리뷰
대한민국
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지역

대한민국

상세 직무 내용

[[extTitle]] M/F ([[id]])


At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.


We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.


Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.


Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.


For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube


Job Responsibilities

  • Ensure Quality Management System for Guerbet Korea & Imaging Solution Korea
  • Develop and maintain the Korean quality assurance system and SOPs in line with the HQ quality management system
  • Fulfill quality activities(Change control, deviation, audit, training, documentation, recall, etc.) by cGMP requirements and Korean regulations.
  • Manage finished product release & and third-party labs
  • Manage the Korean package artworks and Korean drug barcode in compliant with local standards
  • Oversee re-labeling activities – Prepare Korean-specific labeling by MFDs requirement
  • Participate in compliance audits as an auditor/auditee and respond to audit observations
  • Ensure the compliance of regulatory requirements as MFDS registered responsible person for Medical device quality
  • Manage local warehouse with SCM according to the local requirement
  • Provide quality input as a GMP compliance matter expert
  • Register as a qualified person for drug and/or medical device selling and importation
  • Complete QA duties as assigned

Requirements

  • Relevant qualification in bachelor’s degree(pharmacy, bio, or chemistryrelated background preferred)
  • Around 10 years of experience in QA in the pharmaceutical and/or medical device industry
  • Proficient in MS Office
  • Effective communication and interpersonal skills
  • Good verbal and writing English skills
  • Work systemically according to regulations

Reason to join US

Much more than a Competitive salary,



We offer continued personal development. When you join Guerbet, you :

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.


Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.


Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717

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