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한국얀센 Business Quality Manager

핵심 정보

경력
경력 5년 ↑
학력
대졸(4년제) 이상
근무형태
정규직
급여
면접 후 결정
근무요일
주 5일(월~금)
근무지역
서울 용산구
최저임금계산에 대한 알림 하단에 명시된 급여, 근무 내용 등이 최저임금에 미달하는 경우 위 내용이 우선합니다. 본 채용정보는 2024년 1월 1일 부터는  2024년 최저임금을 준수 합니다.

본 채용정보는 마감되었습니다.

(주)한국존슨앤드존슨에서 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: Business Quality Manager (Quality & Compliance Manager)
2. 계열사: 한국얀센 (Janssen)
3. 근무지: 서울시 용산구


[Summary]
1) The BQ Manager is responsible for the quality of, and meeting the applicable requirements for, the products that the LOC markets, or the products that it produces for other companies (including all named-patient materials, product samples and/or clinical supplies).
2) He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities the LOC undertakes including but not limited to GMP/GDP activities, unless agreed to be otherwise managed by other Q&C functions such as GCDO, MAF, CLS, CS and Make Q&C. In this role he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Business Quality Manual.


[Responsibilities]
1) Quality Systems
- Implement the Quality System via transposition of the requirements of the Business Quality Manual.
- Maintain an up to date list of all relevant product sourcing, supply routes (including exports), product licences (marketing authorizations), relevant authorizations (e.g. manufacturing, packaging, importation, warehousing, distribution, testing, narcotics handling, etc.), and TA.
- Prepare, update and approve LOC procedures in accordance with local GxP regulations, BQ Manual and J&J requirements.
- Execute minimum requirements regarding lifecycle management of GxP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity.
- Ensure the provision of appropriate training for all job functions with GxP responsibilities.
- Ensure appropriate internal and external change control systems are in place and are followed.
- Manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the CURVE.
- Monitor quality system performance versus local GxP regulations, BQ Manual and J&J requirements via use of pertinent business and compliance metrics and goals.
- Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews.
- Notify and engage LOC Quality Head and Business Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures.

2) Quality Processes
- Ensure that robust processes are installed and maintained to ensure accuracy of printed packaging (labelling) text, including correct translation from source documents into local product text versions and appropriate review at critical stages, and that all people involved in text management have been trained accordingly.
- Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / Packaging and / or Import Licenses are available and kept up to date for all marketed products.
- Conduct regular (self-)inspections of GxP practices with focus on GMP/GDP activities, that are applicable on the supply chain within the responsibilities of the Local Operating Company.
- Provide an effective procedure and adequate resources to handle product and AE complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner (including outside business hours.
- Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant Q&C, CLS Q&C, Controlled Substance Compliance Manager, the logistic department, JJRC, and any other functions supporting complaint management.
- Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.


[Requirements]
1) Primary degree in Chemistry / Pharmacy / Microbiology / Medicine or equivalent;
2) At least 5 (ideally 10) years’ experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management, Regulatory Affairs and some Sales & Marketing experiences. Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential;
3) Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;
4) Up-to-date knowledge of relevant pharmaceutical legislation and GxP including but not limited to GMP/GDP;
5) Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;
6) Knowledge and full understanding of the J&J Quality Policy (POL 001), and the procedures and processes outlined in this Manual;
7) Full competency in local languages and a working knowledge of English


[JD 확인 및 지원 방법] PC & mobile 지원 모두 가능
www.careers.jnj.com -> Requisition number 1700152404W 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


복리후생

급여제도
4대 보험

근무지위치

(140-702) 서울 용산구 한강로2가 LS용산타워 22-28F

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접수기간 및 방법

마감되었습니다.

시작일
2017.03.20 14:00
마감일
2017.04.17 11:46

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