[Janssen] Quality Specialist

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: Quality Specialist 2. 계열사: 한국얀센 (Janssen) 3. 근무지: 서울시 용산구 4. 근무 형태: Fixed Term [Summary] - Responsible for the quality of, and meeting the applicable requirements for, the products that the LOC markets, or the products that LOC produces for other companies. - Responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes. This role has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Commercial Quality Manual. - Support Internal Audit and HA inspection for auditing and documentation [Responsibilities] - Receive Product Quality Complaints (PQC) from internal/external channels, provide input into the compliant handling system for investigation. Communicate with the complainant for collection of product information, coordinate retrieval of field samples and product compensation. - Ensure complaint intake and review investigation and closure are timely complete. Communicate with physician, customer and pharmacy association to provide appropriate and timely response. - 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 - Coordinate and document internal meetings for resolving significant/critical complaint issues - Manage call center for PQC call handling and reporting - Perform PQC trainings for internal employees and call center agents - Eusure quality training management for Korea LOC, and monitor training metric to be in green - Perform an admin role of the quality training eLMS(Summit), and manage and operate Quality Trainings within the eLMS according to Training Matrix - Manage local Quality Training Matrix according to Korea LOC Quality Manual - Update LOC employee’s list monthly and be in control of their quality trainings and make changes to the list in eLMS - Execute as an SME for training management project in global and local - As a TruVault System Document Controller, run document routing and make updated documents effective - Prepare quality metric data for QSMR and monthly review for compliant handling - Perform and monitor Periodic Document Review in TruVault and update it to APAC regional CQ team. - Support document revision and creation in TruVault within CQ team including Quality Manual - Manage Korea LOC Quality Manual binder in TruVault [Requirements] - At least 2 years’ experience in the pharmaceutical or related industry - Hands-on experience in QA - ETS experience such as TrackWise system is preferred - eLMS experience such as Summit system is preferred - Excellent interpersonal and communication skills - Problem solving and project management skills, clear thinker and ability to work across functions/groups - Proficiency in written and oral English - In depth knowledge for the GxP and Quality associated environment - Experience of PQC, Quality Issue Investigation, CAPA and Change Control [지원 방법] www.careers.jnj.com 접속 -> Position Number 2206021394W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행 [제출 서류] 국&영문 자유 양식의 이력서/자기소개서 [서류 마감일] 채용시 마감 [For more Johnson & Johnson] - J&J Careers 유튜브 채널 : https://www.youtube.com/channel/UCZEsWOZwbcjcXHrgYq7sP4Q - J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/ - J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/ - J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info [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. - 온라인 접수시 “Create Your Account” 를 통해 개인 이메일 계정을 등록하신 후 온라인 지원 프로세스를 진행할 수 있습니다. Ex) G-mail/Naver/Daum 등 - 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com Qualifications - Primary Location South Korea-Seoul-Yongsan-gu- Organization Janssen Korea, Ltd. (7220) Job Function Quality Requisition ID 2206021394W