[ROLES & RESPONSIBILITIES]
1. Reporting to the SQA Team Leader, about GMP related issues. The Quality Assurance is responsible for coordinating the activities required to meet quality standards.
QA 팀장에게 GMP 관련 이슈사항을 보고하고, 품질기준이 충족할 수 있도록 요구되는 활동을 조율.
2. Continuously monitoring Alvogen korea plant quality assurance systems, and make quality and operational improvements as needed through the Alvogen korea management and change control systems, so as to comply with all requirements to satisfy the regulatory requirements in the markets in which Alvogen korea operate, including MFDS and PIC/s standards, and as requested by Alvogen Group.
알보젠 그룹 및 규제기관에서 요구하는 품질기준을 충족하기 위해 품질보증 시스템을 지속적으로 모니터링
3. Site master file management
SMF 관리
4. Preparation and management of Product Master File.
제품표준서 작성 및 관리
5. Review of Master Batch Record
마스터 제조기록서 검토
6. Review of SOP and Attachments
SOP 및 별첨 검토
7. Gap assessment for regulatory Authority compliance
규제당국 법령 업데이트에 따른 갭 분석
8. Management of Investigation Medicinal Product(IMP)
임상시험용 의약품 관리
9. GTIN code management
표준코드 관리
10. Management of Controlled substances
마약류(향정) 의약품 관리
11 Proofreading and Change control related to Artwork of Label, Carton, Foil, Insert. Etc.
라벨, 카톤, 호일, 설명서 등에 대한 표시자재 교정(RA) 및 변경관리
12. Supplier Audit management
공급 업체 평가
13. Reporting and reviewing of NDMA documents
NDMA 불순물평가 자료 제출
14. QUMAS & Compliance wire system management
전자문서시스템/교육관리 시스템 관리
[QUALIFICATIONS]
1. University degree in areas such as Pharmacy, Chemistry, Pharmaceutical Engineering or equivalent.
- 약학, 화학, 제약공학 또는 이와 동등한 분야의 대학 학위
2. Professional experience – preferably 3 years, of uninterrupted work experience in the production and/or control of pharmaceuticals.
- 제약회사 3년이상의 경력
3. To be well acquainted with the MFDS standards, and preferably also European standards on Good Manufacturing Practice (EU-GMP), as well as other international GMP standards.
- 국내 식약처 GMP 기준 및 국제 GMP 기준 이해 및 숙지
4. Good communication and English skill, OA skill
- 원활한 커뮤니케이션 및 영어 능력, OA 능력.
[ROLES & RESPONSIBILITIES]
1. Reporting to the SQA Team Leader, about GMP related issues. The Quality Assurance is responsible for coordinating the activities required to meet quality standards.
QA 팀장에게 GMP 관련 이슈사항을 보고하고, 품질기준이 충족할 수 있도록 요구되는 활동을 조율.
2. Continuously monitoring Alvogen korea plant quality assurance systems, and make quality and operational improvements as needed through the Alvogen korea management and change control systems, so as to comply with all requirements to satisfy the regulatory requirements in the markets in which Alvogen korea operate, including MFDS and PIC/s standards, and as requested by Alvogen Group.
알보젠 그룹 및 규제기관에서 요구하는 품질기준을 충족하기 위해 품질보증 시스템을 지속적으로 모니터링
3. Site master file management
SMF 관리
4. Preparation and management of Product Master File.
제품표준서 작성 및 관리
5. Review of Master Batch Record
마스터 제조기록서 검토
6. Review of SOP and Attachments
SOP 및 별첨 검토
7. Gap assessment for regulatory Authority compliance
규제당국 법령 업데이트에 따른 갭 분석
8. Management of Investigation Medicinal Product(IMP)
임상시험용 의약품 관리
9. GTIN code management
표준코드 관리
10. Management of Controlled substances
마약류(향정) 의약품 관리
11 Proofreading and Change control related to Artwork of Label, Carton, Foil, Insert. Etc.
라벨, 카톤, 호일, 설명서 등에 대한 표시자재 교정(RA) 및 변경관리
12. Supplier Audit management
공급 업체 평가
13. Reporting and reviewing of NDMA documents
NDMA 불순물평가 자료 제출
14. QUMAS & Compliance wire system management
전자문서시스템/교육관리 시스템 관리
[QUALIFICATIONS]
1. University degree in areas such as Pharmacy, Chemistry, Pharmaceutical Engineering or equivalent.
- 약학, 화학, 제약공학 또는 이와 동등한 분야의 대학 학위
2. Professional experience – preferably 3 years, of uninterrupted work experience in the production and/or control of pharmaceuticals.
- 제약회사 3년이상의 경력
3. To be well acquainted with the MFDS standards, and preferably also European standards on Good Manufacturing Practice (EU-GMP), as well as other international GMP standards.
- 국내 식약처 GMP 기준 및 국제 GMP 기준 이해 및 숙지
4. Good communication and English skill, OA skill
- 원활한 커뮤니케이션 및 영어 능력, OA 능력.