Johnson & Johnson Careers
[존슨앤드존슨] Associate Manager, Deliver Q&C
Requisition ID: 1905734019W
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
- 포지션: Associate Manager, Deliver Q&C (Pharmaceutical)
- 근무지: 서울시 용산구
- 근무형태: 정규직(Regular)
The position is designed to ensure the implementation of Quality System Compliance within the scope of DELIVER activities in KOREA and supporting North Asia cluster & Regional DELIVER Q&C Strategies as well on the quality and compliance execution, through:
- Implementing and evaluating a highly effective Quality & Compliance Function and Awareness within DELIVER Korea Community – Mainly Pharm and support to cross sectors in Korea
- Independently partnering with KOREA business quality, Regional DELIVER, JNJ Third Party quality and operational leader as well as another affiliate for DELIVER Q&C.
- Close collaboration with business quality, local regulatory team, Supply Chain, and JNJ Third Party Logistics/Supplier.
- Ensuring KOREA Distribution Center under scope of DELIVER meets all appropriate related requirement such as: regulatory authority, and sector requirements.
- Support and maintain regional DELIVER Q&C Dashboard as per agreed target
- Implement and support Quality System implementation within the scope of DELIVER, includes ensuring KOREA sites meet DELIVER Distribution Center QSCAN, GWP requirements and conducting internal audit to JNJ Third Party Logistics/Supplier as well as ensure satisfactory closure of JJRC AAP of JNJ Third Party Logistics/Supplier.
- Support CIP program related to DELIVER Q&C in KOREA.
- Ensure compliance of KOREA sites to the Global and Regional Guidelines and Policies including enterprise standards related to Quality and Regulatory Compliance for DELIVER.
- Established quality agreement at all KOREA JNJ Third Party Logistics/Supplier for warehousing, transportation and other 3rd party services related.
- Flawless execution on global standard requirement for repack/relabel facilities at KOREA under scope of DELIVER.
- Ensure timely JNJ Distribution Center quality reviews are conducted and actively participate on management review of site business quality
- Support an appropriate and timely closure of related to quality and compliance customer complaint at JNJ Third Party Logistics/Supplier of KOREA.
- Maintain and monitor system compliance such as for NC/CAPA, training program, change.
- Partners with DELIVER Operations to implement business solutions and leads compliance efforts associated with complex projects and activities through effective implementation of the Audit Action Plan (AAP) process
- Supplier Audit program and ensure inspection readiness and provide strategic focus for quality and compliance by working with appropriate functional areas to identify continuous improvement opportunities
- Coordinates and reports timely and accurate metrics and analysis per J&J policies. Reporting responsibilities within KOREA include (but are not limited to): Metric evaluation and reporting in CURVE entry updates.
- Accountable for Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the Distribution Center
- Accountable for accurate and timely communication of temperature control excursions occurring within the Distribution Center to appropriate partner
- Accountable for the investigation of temperature control excursions and subsequent remediation activities
- Accountable for overseeing the controls and quality standards for all distribution
1. More than 5-year experience in QC or QA Function of any Medical devices or Pharmaceuticals Industry
2. Bachelor’s Degree in science (Life Sciences, Microbiology, etc.) or Engineering required.
3. Good knowledge of Good Distribution Practices (GDP), GMP and validation- demonstrated knowledge and application of QSR, ISO9001, ISO13485 and other international standards.
4. Certified Auditor of GMP, ISO 9001, or ISO 13845.
5. Knowledge of manufacturing environment or repackaging/relabeling environment
6. Fluency in English language required.
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