[Roles & Responsibilities]
1.분석기기 관리 및 운영담당자 Analytical Instrument Management & Operation
- 분석기기 구매 및 도입 지원 (Support analytical instrument purchase and introduction)
- 기기 적격성평가(IQ/OQ/PQ) 수행 및 문서화 (Perform and document qualification (IQ/OQ/PQ) of instruments)
- 분석기기 유지보수 및 교정 관리 (Conduct regular maintenance, calibration, and GMP documentation)
- 분석기기 트러블슈팅 및 기술 지원 (Troubleshoot equipment issues and provide technical support)
- 영어 문서 작성 가능자 (Ability to write technical documents in English)
2.제품, 원료 시험방법서 제ㆍ개정 (Establishment and Revision of Test Methods for Products and Raw Materials)
3.시험방법 밸리데이션, 공정 밸리데이션 시험 및 세척 밸리데이션 시험, 관련 계획서 보고서 작성 (Method validation, Process Validation test, and Cleaning validation Test, including preparation of protocol & report. )
4. 시생산 제품 시험 및 시험방법 기술 이전 시험 (Technology transfer testing of analysis method & engineering product testing)
5. 의약품 동등성 시험, 인산결합 시험, 신제품 프로젝트 관련 스터디 등. (Pharmaceutical Equivalence, Phosphate
binding study, study the relevant new product project, etc. )
[Qualfiations]
1. People with practical experience in chemical analysis, scientific knowledge, analytical thinking, and problem-solving skills are preferred.
2. Prefer applicants with MS Office technology, analysis technology, chemical, and GMP knowledge, and the ability to use and manage analytical devices
- HPLC, GC, AA, UV, Dissolution, ICP/MS etc.
3. More than 5 years of experience in the pharmaceutical field.
4. Preferential treatment for experienced global projects leading.
5. A person who graduated with a bachelor's degree and majored in pharmacy, chemistry, biology, or similar fields.
[Roles & Responsibilities]
1.분석기기 관리 및 운영담당자 Analytical Instrument Management & Operation
- 분석기기 구매 및 도입 지원 (Support analytical instrument purchase and introduction)
- 기기 적격성평가(IQ/OQ/PQ) 수행 및 문서화 (Perform and document qualification (IQ/OQ/PQ) of instruments)
- 분석기기 유지보수 및 교정 관리 (Conduct regular maintenance, calibration, and GMP documentation)
- 분석기기 트러블슈팅 및 기술 지원 (Troubleshoot equipment issues and provide technical support)
- 영어 문서 작성 가능자 (Ability to write technical documents in English)
2.제품, 원료 시험방법서 제ㆍ개정 (Establishment and Revision of Test Methods for Products and Raw Materials)
3.시험방법 밸리데이션, 공정 밸리데이션 시험 및 세척 밸리데이션 시험, 관련 계획서 보고서 작성 (Method validation, Process Validation test, and Cleaning validation Test, including preparation of protocol & report. )
4. 시생산 제품 시험 및 시험방법 기술 이전 시험 (Technology transfer testing of analysis method & engineering product testing)
5. 의약품 동등성 시험, 인산결합 시험, 신제품 프로젝트 관련 스터디 등. (Pharmaceutical Equivalence, Phosphate
binding study, study the relevant new product project, etc. )
[Qualfiations]
1. People with practical experience in chemical analysis, scientific knowledge, analytical thinking, and problem-solving skills are preferred.
2. Prefer applicants with MS Office technology, analysis technology, chemical, and GMP knowledge, and the ability to use and manage analytical devices
- HPLC, GC, AA, UV, Dissolution, ICP/MS etc.
3. More than 5 years of experience in the pharmaceutical field.
4. Preferential treatment for experienced global projects leading.
5. A person who graduated with a bachelor's degree and majored in pharmacy, chemistry, biology, or similar fields.