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. Position: QA Analyst, SCM North Asia
2. Location: 서울시 용산구
1. Distribution and Inventory Management Process
- Responsible for overseeing the controls and quality standards for all distribution and inventory management in Korea.
- Responsible for the quality oversight of all product quality holds and field actions impacting the distribution centers.
- Responsible for providing QA evaluation for the company's quality and distribution process capabilities against company and industry standards and regulatory expectations.
- Responsible for adherence to temperature control and monitoring requirements within facility and during transportation.
- Responsible for overseeing the validation of cold chain including facilities and controlled ambient pack out and transportation lanes.
- Responsible for accurate and timely communication of QA input for temperature control excursions occurring within DC to appropriate partner.
- Ensure the investigation of temperature control excursions and subsequent remediation activities.
- Ensure implementation of appropriate process and quality oversight for labeling activities at appointed distribution centers
- Ensure implementation of processes for loan kit activities at appointed distribution centers as per applicable enterprise standard procedures
2. Quality Management Systems.
- Provide support to Business Quality for the implementation and improvement of Quality Management Systems
- Responsible for the appropriate handling of distribution related customer complaints including track and trend and mitigation of quality related issues for DC's.
- Responsible for the controls and quality standards of Quality Management System including Corrective/Preventive Action, Non-Conformance and Change Control, Document Control, GMP/GDP training management, Quality agreements. etc.
- Ensure CLS related standards are effectively implemented, and on-going compliance by CLS Operations and 3rd Party under CLS scope.
- Responsible for the successful management of Health Authority inspections (e.g: MFDS) as well as other logistics and transportation related inspections in Johnson & Johnson distribution Centers
- Support Business Quality for any of JJRC audit at marketing company relating to quality and compliance activities at distribution centers such as supplier audit report, quality agreement, etc.
- Responsible for timely and accurate metrics and reports as J&J policies.
- Establish appropriate goals & objectives and business measurements.
4. Distribution Supplier Quality Management
- Responsible for qualification of distribution, logistics and transportation.
- Responsible for Quality Management of distribution, logistics and transportation.
- Supplier Management
- Bachelor's degrees or above
- More than 2 years QA experience in Medical Devices and/or Pharmaceuticals
- Excellent English communication (Writing & Oral) ability
- Good knowledge of cGMPs, GDP, Standard procedures and other Quality Systems and Guidelines of Medical Devices and/or Pharmaceuticals.
- Good knowledge of Quality Management system and local regulations related to the scope of CLS
- Knowledge of the Local regulatory requirements related to distribution of products
- Good knowledge of the distribution practices
- Knowledge of the process validation and qualifications
- Good knowledge and competency on Quality Systems. (CAPA, Change Control, Non-Conformance, etc.)
- Experience of MFDS, internal audit and supplier audit is preferred.
- Skills of problem solving, risk assessment, analytical thinking, data analysis, process setting
[JD 확인 및 지원 방법 ] PC & mobile 지원 모두 가능
www.careers.jnj.com -> Requisition number 1805638370W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
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