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Quality Control 1 Team Specialist |
지원하기 |
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Job
Description |
ㆍ제품 시험(공정밸리데이션 및 출하시험) & 안정성 시험
ㆍ분석기기 표준작업지침서 제개정
ㆍ시험규격서 제개정
ㆍ기준일탈, 일탈 실험실 원인조사 및 재발방지 대책 수립 |
Job Requirements |
ㆍMore than 5 years-experience in related field
Quality 분야에서 5년 이상의 경력
ㆍBachelor's Degree or above, majoring in Chemical or Pharmaceutical.
4년제 대졸, 화학 또는 제약 관련 전공자
ㆍGood communication skill, OA skill, knowledge of pharmaceuticals,
Analysis Equipment Skill, etc.
원활한 커뮤니케이션 능력, OA 능력, 제약에 대한 지식, 분석장비 사용기술 등 |
계약형태 |
ㆍ정규직 (수습기간 3개월) |
근무지 |
ㆍ향남 공장
* 회사의 업무 상황에 따라 변경 가능 |
채용인원 |
ㆍ0명 |
지원방법 |
ㆍ홈페이지 지원 |
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Job
Description |
ㆍBatch manufacturing/packaging directions and records management
제조/포장 지시 및 기록서 관리
ㆍManagement and supervision of GMP standard documents compliance
GMP 기준 준수 여부 감독 및 관리
ㆍMonitoring and management of manufacturing environment
제조환경 모니터링 및 관리
ㆍReviewing and approving GMP documents
GMP 문서의 검토 및 승인 |
Job Requirements |
ㆍA registered pharmacist in the Republic of Korea.
약사 면허 보유자
ㆍHolding a bachelor’s degree of pharmacy or above.
4년제 대졸 이상, 약학 전공자
ㆍProfessional experience – work experience in the production and pharmaceutical industry.
제약 회사 생산 근무 경력
ㆍTo be will acquainted with the MFDS standards and preferably also European standards on
Good Manufacturing Practice(EU-GMP), as well as other international GMP standards.
MFDS 표준, EU-GMP 및 기타 국제 GMP 표준에 대한 잘 알고 있어야 함.
ㆍGood communication skill, GMP skill
원활한 커뮤니케이션 능력, GMP 지식 등 |
계약형태 |
ㆍ파트타임 (협의가능) |
근무지 |
ㆍ향남 공장
* 회사의 업무 상황에 따라 변경 가능 |
채용인원 |
ㆍ0명 |
지원방법 |
ㆍ홈체이지 지원 |
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Job
Description |
ㆍReview dossier and check feasibility to get MA and/or DMF for drug products and drug
substances.
완제의약품 허가 또는 원료의약품 DMF등록자료 검토 및 적합성 조사.
ㆍProceed pre-review application (specification & test method and/or safety & efficacy) to
confirm feasibility.
사전검토 민원(기준및시험방법 그리고/또는 안전성유효성) 진행하여 식약처로부터 적합성 확인.
ㆍSetting-up regulatory strategy through dossier review regarding new project.
도입 및 개발 제품 검토를 통한 지원 및 허가전략 수립.
ㆍConduct IND submissions and hand it according to project plan in timely manner.
신규 제품 계획에 따른 임상시험계획서 제출 및 승인일정 수립.
ㆍCommunication with MFDS and suppliers to prepare queries and deficiencies
(S&T, S&E and GMP).
식약처 또는 관련 회사로부터 문의 그리고/또는 요청자료에 대한 커뮤니케이션.
ㆍTime-line checking of launch preparation: artwork, registration for ID code, pricing and
barcode etc.
신규제품 발매 준비상황 확인 : 제품 자재 디자인, 낱알식별코드 등록, 약가, 바코드 등록 등.
ㆍPerform to proceed MA variation according to change control from QA or toll
manufacturer.
품질관리팀 또는 수탁사로부터 변경관리 자료 접수 후 허가변경 진행
ㆍManage MA renewal based on MA expiry date and re-evaluation of products
품목허가 유효기간에 따라, 전체 허가/신고 품목 품목갱신 관리 및 품목 재평가 관리
ㆍTimely updating of internal database
내부 데이터베이스 업데이트
ㆍCheck and follow up pharmaceutical regulations and MFDS notification frequently.
의약품 관련 규정 및 식약처 공지/지침 확인 후 영향평가
ㆍParticipate in TFT, seminar, news and training related with regulation and job.
의약품 관련 규정 및 업무와 관련된 세미나, 기사, 교육 및 전략팀(TFT) 참석 및 사내 내용공유
ㆍReview the protocol and report of PMS(Post-Marketing Surveillance)/RMP
(Risk Management Plan)
신약등의 재심사/위해성관리계획 관련 자료 검토 |
Job Requirements |
ㆍAn advanced degree is required in chemistry, biology, biochemistry or pharmacy preferred
ㆍBusiness level of English (both Speaking & Writing)
ㆍ5~7 or more years of pharmaceutical experience is preferred.
ㆍGood knowledge of pharmaceuticals related regulations
ㆍAbility to manage multiple assignments simultaneously, work independently and as part of
a team.
ㆍRequires initiative
ㆍGood ability in searching and interpreting medical literature.
ㆍGood interpersonal and team skills with ability to build consensus.
ㆍResults-oriented work ethic.
ㆍStrategic problem solving skills.
ㆍHighly motivated with high personal and ethical standards
ㆍCross-Functional Collaboration for Common Goal |
계약형태 |
ㆍ정규직 (수습기간 3개월) |
근무지 |
ㆍ강남역 본사
* 회사의 업무 상황에 따라 변경 가능 |
채용인원 |
ㆍ0명 |
지원방법 |
ㆍ홈체이지 지원 |
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Medical Information Specialist |
지원하기 |
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Job
Description |
ㆍReview promotional materials on Alvogen products that are intended for the promotion
of products, education, and distribution to health professionals, other customers, or the
public in Korea by Alvogen colleagues.
ㆍReview agreements with partners etc. who engage in promotional activities.
ㆍReview and approve medical contents generated by Alvogen Korea ensuring that it meets
the minimum quality criteria and local requirement, to use the medical contents in Korea.
ㆍGenerate medical content, provide the responses to the people who request, maintain
all the documents, and record cases requested in the tracker |
Job Requirements |
ㆍBachelor’s or master’s degree in bio-science, medicine, or pharmacology preferred
ㆍOver 7~8 years of experience in the Medical Information works or Medical Scientific
Liaison works is preferred
ㆍIdeally, over 2 years of experience in the pharmaceutical industry is preferred
ㆍHigh fluency in Korean and command of English are required |
계약형태 |
ㆍ정규직 (수습기간 3개월) |
근무지 |
ㆍ강남역 본사
* 회사의 업무 상황에 따라 변경 가능 |
채용인원 |
ㆍ0명 |
지원방법 |
ㆍ홈체이지 지원 |
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Job
Description |
ㆍBS Oversee:
- Forecasting & Budgeting
· 5YP 1Time, Forecasting 3 times per year
- Analysis
· Conduct in-depth analysis to gain insights into operational drivers affecting financial
status: Variances and trends. 영업/재무 레버리지, 자기 자본비율, 부채 비율, 유동 부채 비율,
이자율 보상 배율, 차입금 의존도
(Return on Equity, Leverage ratio, Debt-to-Equity ratio, Interest coverage ratio,
Borrowings to total assets)
ㆍWorking Capital Analysis:
Working capital Model Implementation to optimize
매출/매입채권 회전율, 재고자산회전율, 매입채무 회전율 등
ㆍAd-hoc Analysis and Projects:
Ad-hoc OPEX analysis as required by senior management. |
Job Requirements |
ㆍBachelor's degree or equivalent in Finance, Accounting, or a related field preferred.
ㆍUnder 8 years of professional experience, including 2~3 years in Financial Planning and
Analysis (FP&A) preferred.
ㆍPreferably, experience in the multinational healthcare industry.
ㆍProficient in MS Office, particularly in spreadsheet applications for report generation and
data management.
ㆍExcellent communication skills, with a demonstrated ability for cross-functional
understanding, collaboration, and negotiation.
ㆍGood command of English, both spoken and written. |
계약형태 |
ㆍ정규직 (수습기간 3개월) |
근무지 |
ㆍ강남역 본사
* 회사의 업무 상황에 따라 변경 가능 |
채용인원 |
ㆍ0명 |
지원방법 |
ㆍ홈체이지 지원 |
필수제출서류 |
ㆍ영문이력서 |
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