핵심 정보
- 경력
- 경력 5년 ↑
- 학력
- 대졸(4년제) 이상
- 근무형태
- 계약직 1년
- 급여
- 면접 후 결정
- 근무요일
- 주 5일(월~금)
- 근무지역
- 서울 용산구
본 채용정보는 마감되었습니다.
(주)한국얀센에서 채용공고가 시작되면 이메일로 알려드립니다.
상세요강
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
1. 포지션: MAF Quality & Compliance Specialist (contractor)
2. 계열사: 한국얀센 (Janssen)
3. 근무지: 서울시 용산구
4. 근무기간: 1년
[Summary]
The MAF Q&C Specialist is responsible for ensuring compliance with local laws and regulations, standards, as well as local compliance with global processes and procedures with regard to all MAF activities. The Q&C Specialist ensures local support is provided for audits for MAF activities and inspections, development, implementation and oversight of CAPAs. The MAF Q&C Specialist ensures local helpdesk support is provided for local regulation issues and questions
[Responsibilities]
1) Procedural Documents Management & Control
- Perform Impact Assessment of cross-pharma SOPs and/or regional SOPs within due date
- Review and update/obsolete local procedural document either due to above-country changes, and/or according to the periodic review schedule (in every 3 year).
2) Quality and Compliance Management
- Ensure compliance with local laws and regulations, standards, as well as compliance with global processes and procedures.
- Ensure audit and local regulatory inspection readiness and appropriate conduct and follow-up(CAPA)
- Prepare QC checklist and Perform quality monitoring activities
- Run & Report MAF Compliance Metric to regional Compliance Lead periodically
3) Training Management of MAF team
- Complete and maintain local training curriculum
- Assign the training to appropriate employees when global/regional/local Procedural documents update
- Support SOP and local requirements training of new-hire and existing staff.
4) Contact Person as local Compliance lead
- Advise SOP issues / questions
- Provide the information of local situation and/or feedback when regional compliance lead requests
5) Collaborate with business partners
- Responsible of establishing effective relationship with internal employees and stakeholders
- Responsible of participating in Business Quality Meeting & HCC Community and participate in periodically as MAF representative
[Requirements]
1) A minimum of 5 years of previous Pharmaceutical Industry experience is required, with at least 3 years of GxP experience including clinical development and/or quality assurance.
2) Understanding of regulatory policies and guidelines related to medical affairs activities is required.
3) Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
[JD 확인 및 지원 방법] PC & mobile 지원 모두 가능
www.careers.jnj.com -> Requisition number 1700147011W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
[제출 서류]
영문 자유 양식의 이력서/경력 기술서/자기소개서
[서류 마감일]
채용시 마감
[유의사항]
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 있습니다.
- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com
[이메일 문의]
recruitment-jnj@ITS.JNJ.COM
기업정보
이 기업의 다른 공고 (5건)
이어보는 Ai매치 채용정보
사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.
사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.