Johnson & Johnson Careers
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[Janssen] Quality Specialist
Requisition ID: 1805621084W
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
1. 포지션: Quality Specialist
2. 계열사: 한국얀센 (Janssen)
3. 근무지: 서울시 용산구
4. 근무 기간: 1년 6개월
1) BQ 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.
2) He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes. 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.
1) Receive Product Quality Complaints(PQC) from internal/external channels, provide input into the complaint handling system for investigation. Communicate with the complainant for collection of product information, coordinate retrieval of field samples and product compensation.
2) Ensure complaint intake and review for investigation and closure are timely completed. Communicate with physician, customer and pharmacy association to provide appropriate and timely response.
3) Perform periodic PQC reconciliation with related functions and call center. Perform complaint trend analysis periodically and, if needed, escalate significant/critical complaint issues to management for further review, discussion, and follow up
4) Coordinate and document internal meetings for resolving significant/critical complaint issues.
5) Manage call center for PQC call handling and reporting and perform PQC trainings for internal employees and call center agents
1) Perform qualification, monitoring, periodic on-site audit and off-site assessment of suppliers and distributors. Communicate with related functions, external suppliers and distributors for qualification and monitoring timely. Manage and document quality agreement between Janssen Korea and suppliers.
2) Ensure to manage proper Approve Supplier list(ASL) and Approved Distributor List(ADL). Ensure suppliers and distributors status, information and records in TrackWise ETS.
1) Ensure appropriate change control procedures are followed. Monitor change control status for timely closure and support issues related to TrackWise ETS.
2) Ensure appropriate Quality Issue(QI), Investigation, CAPA procedures are followed. Monitor QI/CAPA status for timely closure, and support issues related to TrackWise ETS.
3) Perform the TrackWise ETS training for internal users.
4) Prepare quality metric data for QSMR and monthly review for complaint handling, change control, quality issue, CAPA, purchasing control. Keep related trackers up to date.
5) Update and keep product list up to date.
6) Establish and revise LOC procedures in accordance with local GMP/GDP, BQM and J&J requirements for complaint handling, change control, quality issue, CAPA, purchasing control.
7) Support internal audit and HA inspection for auditing and documentation
8) Oversight End to End labeling and artwork process and support issues for the process
1) At least 3 years’ experience in the pharmaceutical or related industry
2) Hands-on experience in QA and TrackWise system is preferred
3) Excellent interpersonal and communication skills
4) Problem solving & project management skills, clear thinker and ability to work across functions/groups
5) Proficiency in written and oral English
[JD 확인 및 지원 방법]
PC & mobile 지원 모두 가능
www.careers.jnj.com -> Requisition number 1805621084W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
영문 자유 양식의 이력서/자기소개서
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
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- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com
Janssen Korea, Ltd. (7220)