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: QA Specialist
2. 계열사: 존슨앤드존슨 메디칼 (MedTech)
3. 근무지: 서울시 용산구
4. 근무 형태: Regular
1. Ensure compliance in drug import business
2. Implement and supervise tasks regarding drug import and distribution (e.g. Handling QC testing (outsourced), supervising receiving, warehousing and releasing, T&T reporting)
3. Attend required seminar as a registered pharmacist of drug importer
4. Implement and execute quality management system for marketed products in J&J MedTech Korea
5. Act as quality representative for responsible business unit to enable the business in a compliant and efficient way.
6. Collaborate with cross-functional / cross-regional team for highest quality compliance standards.
7. Support engagements with government agencies such as shaping regulations and participating in inspections.
8. Drive process efficiencies with operational improvement and digital solutions.
9. Participate in quality system improvement initiatives.
10. Document and maintain standard operating procedures for interactions with internal and external requirements.
11. Communicate information and present status updates on project activities to key internal/ external stakeholders.
12. Collaborate with local cross-functional team and regional/global quality and compliance team.
13. Ensure compliance with the Health Authority regulations and interpretations.
14. Influence industry bodies to ensure Industry perspective is properly followed.
15. Build and maintain good relationship with relevant regulatory bodies, external bodies, contractors and corporate partners which will have direct impact on Commercial Quality
- Pharmacist license required
- Bachelor’s degree (or higher) in Biochemistry, Microbiology, Biotechnology, Veterinary or other related majors
Experience and Skills:
- Proven experience in handling drug import as a registered pharmacist
- Comprehensive understanding in Korea Pharmaceutical Device Act regarding drug import business
- In-depth knowledge in quality management system in healthcare industry
- Proficient in English both verbal and written communication
- Excellent communication and interpersonal skills
- Experience in handling biologics
- Regular commute (1~2 times a week) to warehouse facility located in Gochon, Gimpo-si
- When required, accompany and support on-site overseas inspection
www.careers.jnj.com 접속 -> Position Number 2306140540W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
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- J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info
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