Quality Assurance(QA) Specialist
Tasks
- Register as a qualified person for medical device importatioAct as site Quality lead for regulatory agencies and corporate interface
- Ensure Quality Management System for Guerbet Korea & Imaging Solution Korea
- Develop and maintain the local quality assurance system and SOPs in line with the HQ quality management system
- Ensure all cGMP requirements are fulfilled for released of finished goods (drug products and medical devices) in accordance with MFDS requirement
- Manage the process that develops, establishes, and maintains quality assurance programs, policies, process, procedures and controls ensuring that performance and quality of finished products (drug products and medical devices) in accordance with MFDS requirements
- Identify, develop and execute quality plans and project timelines to meet group, site and company goals
- Fulfill quality activities(Change control, deviation, product complaint, audit, training, documentation, recall, etc.) by cGMP requirements and Korean regulations.
- Report to Corporate and support domestic customer response in case of product complaints and prepare for the complaint trend report
- Prepare for regular inspection by the MFDS
- Establish, fulfill and evaluate annual training plan
- Receive Annual Product Quality Review from the production site and draft local report
- Manage finished product release(using SAP system) & and third-party labs including method transfer
- Manage the Korean package artworks and Korean drug barcode in compliant with local standards
- Oversee incoming inspection of the finished products for physical appearance and label codes
- Oversee re-labeling activities – Prepare Korean-specific labeling by MFDS requirement
- Manage local warehouse with Supply Chain team according to the local requirement
- Provide quality input as a GMP compliance matter expert
- Manage the reference/retention samples process
- Interact with Corporate or APAC support groups to drive quality programs.
Requirements
- Relevant qualification in bachelor’s degree(pharmacy, bio, or chemistry-related background preferred)
- Around 7~10 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
Information
Apply
1차 서류전형
2차 면접전형
한글이력서, 영문이력서 (각종 증빙서류는 서류전형합격자에 한해 추후제출)
The Others
면접은 서류전형 합격자에 개별통지 합니다.
국가보훈대상자와 신체장애자는 관련서류 제출시 관계법에 따라 우대함.
모든 서류는 반드시 MS Word로 작성하기 바랍니다.
제출하신 서류는 일체 반환하지 않습니다.
입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.
기타 문의사항은 E-mail로 문의바랍니다.
Ai Keywords
경력 수준
근무 지역
직종
업종
주요 업무
자격 요건
채용 요약
Company
At Guerbet, we build lasting relationships so that we enable people to live better.
게르베코리아는 1998년에 설립된 게르베 그룹의 한국 법인입니다.
게르베코리아가 제공하는 대표적인 제품으로는 MRI 조영제인 도타렘®, X-ray 조영제인 제네틱스®, 텔레브릭스®, 그리고 Marcel Guerbet가 1901년에 개발한 세계 최초의 요오드 조영제인 리피오돌® 등이 있습니다.
게르베코리아는 세계 최고의 의약품 공급을 통해 여러분께 가장 신뢰받는 전문의약기업으로 확고히 자리매김하고자 합니다.
연구 개발에 대한 끊임없는 노력과 세계 최고의 의약품 생산에 대한 열정이 게르베의 사명임을 기억하고 국민의 건강과 한국 영상의학 분야의 발전에 기여할 수 있도록 항상 최선의 노력을 다하겠습니다.
Guerbet is a global leader in medical imaging, dedicated to improving patient care through innovation. With nearly a century of expertise, the company offers a comprehensive portfolio of pharmaceutical products, medical devices, and AI-driven solutions for diagnostic and interventional imaging. Guerbet invests 9% of its annual revenue in research and development, with dedicated innovation centers in France and the United States.
본 정보는 개인 구직자들의 취업지원을 위해 외국기업취업전문사이트 피플앤잡에서 수집한 정보이며, 채용회사의 사정에 따라 변경될 수 있습니다.
본 정보는 피플앤잡의 동의 및 허락 없이는 재배포 할 수 없습니다.
