[써모피셔사이언티픽코리아] Quality Manager, Clinical Trials
[써모피셔사이언티픽코리아] Quality Manager, Clinical Trials
써모피셔사이언티픽코리아 외국계기업
서울 강남구 광평로 281 수서오피스빌딩
https://blog.naver.com/thermofishercareers
써모피셔사이언티픽(Thermo Fisher Scientific)은 전세계 60여개 국가, 약 90,000명의 직원들과 함께, 연 매출 41조 원 이상을 달성하는 세계적인 과학 회사입니다. 써모피셔사이언티픽은 고객들이 세상을 더욱 건강하고, 깨끗하며, 안전하게 만들 수 있도록 돕는다는 사명을 가지고, 생명 과학 분야 연구 촉진, 복잡한 분석 난제 해결, 환자 진단 개선 및 의약품 개발, 실험실 생산성 향상에 주력하고 있습니다.
써모피셔사이언티픽 코리아는 약 850명의 임직원이 연 매출 7,000억 이상을 달성하고 있습니다.
– About Thermo Fisher Scientific:
(https://corporate.thermofisher.com/en/home.html)
– Job Korea X Thermo Fisher Scientific Korea:
(https://www.jobkorea.co.kr/Super/thermofisher)
– Blog : (http://blog.naver.com/thermofishercareers)
– 카카오톡 ‘써모피셔사이언티픽코리아채용` 친구 추가 후 문의
Job Description
Position Summary
The Manager is to ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Logistics approved procedures and policies, cGMP, cGDP, and regulatory requirements. Liaise with clients, internal and external customers on quality related matters. Also to ensure that supplies, facility and processes are maintained to cGMP standards.
Essential Duties and Responsibility
Manage and lead the quality team to ensure that all quality procedures and cGMP & GDP standards in relation to the clinical supply chain activities
Ensure compliance with applicable Corporate and Divisional Quality Policies and procedures
Hold responsibilities for FCS Korea’s quality system, cGMP & GDP system, safety management system, and ensures that the systems are managed and maintained effectively in accordance to the relevant standards
Responsible for management of non-conformances, (deviations, complaints and quality investigations) and related corrective and preventive actions through to resolution
Identify regulatory and quality training needs, and delivering training
Leads liaison with regulatory bodies, clients and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to clients, suppliers and internal associates on regulatory and quality matters
Identification of facilities and equipment requiring validation and qualification, and the review and approvals of validation related protocols and reports
Leadership role in service and quality improvement initiatives in line with other functional units to improve market competitiveness, including equipment and processes
Leads recall activities in conjunction with other functional units in compliance with established procedures and clients’ requirements
Responsible for monitoring and control of the production environment, facility hygiene, approval and monitoring of suppliers of materials that affect product quality, approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities, designation and monitoring of storage conditions for materials and products, retention of GxP records, and inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality
Ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorization
Responsible for approval or rejection, as he/she sees fit, starting materials, packaging materials, intermediate, bulk and finished products
Responsible for QA batch release
Responsible for authorization of written procedures and other documents, including amendments, and approve specifications, and other Quality Control procedures
Responsible for management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement
Ensure that a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management
Responsible for the management of change control activities
Conduct internal and external GMP audits
Host client and regulatory audits
Perform any other activities as may be required to fulfil business needs
Job Requirements
Bachelor’s degree in life sciences or related medical/scientific field
5+ years of experience in QA of the related field
Previous working knowledge in the pharmaceutical/medical/healthcare settings in the field of quality assurance
Good organizational skills and the ability to manage multiple tasks
Meticulous attention to detail
Good written and verbal communication skills (English and Korean)
Computer Literate
Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
Ability to work independently
Ability to lead teams
Additional Information
커리어수준 : 대리과장.5년이상
급여사항 : 면접 후 협의
고용형태 : 정규직
경력여부 : 경력
Guidelines for Applicants
전형방법
* 전형절차: 서류전형 ⇒ 면접전형 ⇒ 최종합격
* 지원방법: 자사 홈페이지 지원 (아래 접수방법의 홈페이지 링크를 클릭)
제출서류
영문 이력서(CV) 필수 * 지원분야 및 연락처 명시
접수방법 : 홈페이지 https://jobs.thermofisher.com/global/en/job/175820BR
마감일 : 채용시까지
The Others
[회사 및 채용 정보] http://blog.naver.com/thermofishercareers
[채용 문의] 카카오플러스친구 ‘써모피셔사이언티픽코리아 채용’
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- 영문이름은 여권상의 이름과 동일하게 기재 하십시오.
- 입사지원서 내용에 허위 사실이 판명될 경우, 입사가 취소될 수 있습니다.
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