품질관리약사 (QC약사)
- Company
- 외국계 제약회사
- Position
- 품질관리약사 (QC약사)
- Status
- CLOSE
외국계 제약회사에서 다음과 같이 “품질관리약사” 를 찾습니다.
* Job Title: 품질관리약사 (QC Pharmacist)
* Position: 과장 ~ 차장급
* 해당부서: QA (Quality Assurance)
* Gender: Male or Female
* Location: 경기도 향남
* Job Title: 품질관리약사 (QC Pharmacist)
* Position: 과장 ~ 차장급
* 해당부서: QA (Quality Assurance)
* Gender: Male or Female
* Location: 경기도 향남
[POSITION OVERVIEW]
- Manage and Approval of Drug Product Release (의약품 출하 승인)
- Dealing with Various Audit and Inspection (Audit 및 Inspection 대응)
- Compliance of Pharmaceutical Regulations (제약산업 규제 준수)
- Manage and Approval of Drug Product Release (의약품 출하 승인)
- Dealing with Various Audit and Inspection (Audit 및 Inspection 대응)
- Compliance of Pharmaceutical Regulations (제약산업 규제 준수)
[RESPONSIBILITIES]
- Manage and approval of drug product batch release procedure (의약품 출하승인 및 관련 업무)
- Review and monitor the related regulation for compliance to domestic and foreign regulations (국내외 제약산업 관련 규제 추이 및 변화 검토)
- Management of GMP related tasks and documents (자율점검, 포준서 및 SOP 등 GMP 관련 업무 및 문서 관리)
- Management of MFDS audit and Corporate audit (식약처 및 Global headquarter의 audit 등 다양한 audit 준비 및 수검)
- Support GMP site inspection of domestic and foreign (국내외 GMP site의 audit 및 inspection 실시)
- Manage the deviation and related CAPA (일탈 및 관련 CAPA 관리)
- Support consumer complaint management with related team and affiliates (소비자불만 관리)
- Manage and approval of drug product batch release procedure (의약품 출하승인 및 관련 업무)
- Review and monitor the related regulation for compliance to domestic and foreign regulations (국내외 제약산업 관련 규제 추이 및 변화 검토)
- Management of GMP related tasks and documents (자율점검, 포준서 및 SOP 등 GMP 관련 업무 및 문서 관리)
- Management of MFDS audit and Corporate audit (식약처 및 Global headquarter의 audit 등 다양한 audit 준비 및 수검)
- Support GMP site inspection of domestic and foreign (국내외 GMP site의 audit 및 inspection 실시)
- Manage the deviation and related CAPA (일탈 및 관련 CAPA 관리)
- Support consumer complaint management with related team and affiliates (소비자불만 관리)
[REQUIREMENTS]
- Bachelor's degree and above with pharmacist license holder ? MUST
- QA/QC compliance experiences (assistant manager ~ manager grade)
- Good command of English communication skill
- Willing to travel due to business needs
Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently. Only qualified candidates will be contacted for interview. All resumes not contacted will be kept in DB confidentially for future positions.
