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| QUALITY CONTROL 2 Manager |
지원하기 |
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Job
Description |
[Maintain GxP compliance]
ㆍKeep abreast of the requirements and the latest trends in GxP and attend suitable training
to meet those needs.
ㆍProvide training to QC employees on GxP and monitor of training plan, result and
effectiveness.
ㆍPreparation of programs for corrective and preventative actions (CAPA) after inspections
conducted by regulatory bodies, customers, and other external organizations.
[Quality Control Management Roles]
ㆍValidation Activities :
- Plan, coordinate, and execute validation activities, including method validation,
lab equipment qualification, and software validation, in compliance with regulatory
requirements.
- Develop and implement validation/qualification protocols and reports.
ㆍRegulatory Compliance :
- Stay up-to-date with relevant regulations (e.g., MFDS) and ensure laboratory compliance.
- Assist in preparing for and participating in regulatory audits and inspections.
- Enhance the accuracy and reliability of test results through data integrity compliance.
ㆍDocumentation and Record-keeping :
- Establish and maintain comprehensive documentation for all validation activities.
- Ensure documentation is accurate, organized, and easily accessible.
ㆍLab Support :
- Provide support to laboratory operations by troubleshooting issues, optimizing processes,
and ensuring efficient workflow.
- Collaborate with laboratory personnel to address quality and technical concerns.
ㆍTraining and Development :
- Train and mentor laboratory staff involved in validation activities.
- Promote a culture of continuous learning and skill development.
ㆍChange Control :
- Oversee the change control process and evaluate the impact of changes on validated
processes.
- Ensure changes are implemented following established protocols.
ㆍReporting and Communication :
- Maintain clear and timely communication with relevant stakeholders.
ㆍAudit and Inspection Preparedness :
- Ensure the laboratory is prepared for regulatory audits and inspections.
- Address any findings and implement corrective and preventive actions as needed.
ㆍSafety and Compliance :
- Promote a culture of safety in the laboratory.
- Ensure that safety protocols and ethical standards are followed at all times. |
Job
Requirements |
ㆍUniversity degree or equivalent in Chemistry, Biology, Biotechnology or equivalent.
ㆍMinimum of 10 years professional experience is required (in pharmaceutical industry/QC)
in a GMP regulated environment for the production of pharmaceuticals or
biopharmaceuticals.
ㆍA good background in analytical methods (HPLC, GC, UV, IR). Expertise in MV, PV, CV,
and Stability study. An excellent knowledge of GMP, ICH, USP and global compendia
regulations and guidance's, particularly as related to analytical methods and validations.
ㆍGood computer skills.
ㆍGood command of Korean and English |
| 계약형태 |
ㆍ정규직 (수습기간 3개월) |
| 채용인원 |
ㆍ0명 |
| 근무지 |
ㆍ향남공장
* 회사의 업무 상황에 따라 변경 가능 |
| 지원방법 |
ㆍ홈페이지 지원 |
| 필수제출서류 |
ㆍ국/영문 이력서, 자기소개서 |
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| QUALITY CONTROL 2 Specialist - VALIDATION PART |
지원하기 |
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Job
Description |
[지원자 역량 사항에 따라서 아래 업무 중 보직 결정]
ㆍMethod validation, Process Validation test, and Cleaning validation Test
시험방법 밸리데이션, 공정 밸리데이션 시험 및 세척 밸리데이션 시험
ㆍTechnology transfer testing of analysis method & engineering product testing,
including preparation of protocol & report
시생산 제품 시험 및 시험방법 기술 이전 시험, 관련 시험 계획서 보고서 작성
ㆍElemental impurities analysis / ICH Q3D
금속불순물 시험
ㆍPharmaceutical Equivalence, Phosphate binding study, study the relevant new product
project, etc.
의약품 동등성 시험, 인산결합 시험, 신제품 프로젝트 관련 스터디 등. |
Job
Requirements |
ㆍPeople with practical experience in chemical analysis, scientific knowledge, analytical
thinking, and problem-solving skills are preferred.
ㆍPrefer 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.
ㆍPreferential treatment for experienced pharmaceutical or chemical laboratories.
(less than 15 years)
ㆍPreferential treatment for experienced global projects leading.
ㆍA person who graduated with a bachelor's degree and majored in pharmacy, chemistry,
biology, or similar fields. |
| 계약형태 |
ㆍ정규직 (수습기간 3개월) |
| 채용인원 |
ㆍ0명 |
| 근무지 |
ㆍ향남공장
* 회사의 업무 상황에 따라 변경 가능 |
| 지원방법 |
ㆍ홈페이지 지원 |
| 필수제출서류 |
ㆍ이력서, 자기소개서 |
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| QUALITY CONTROL 1 Specialist |
지원하기 |
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Job
Description |
ㆍTesting of Raw material & Packaging material and in-process and finished products for
release (원료 및 완제품 시험 진행)
- Testing of Raw material & Packaging material and in-process and finished products for
release (원료 및 완제품 시험)
ㆍManagement of narcotics (마약류 관리)
- Reporting to narcotics information management system (NIMS)
(마약류 통합관리시스템 입력 및 보고)
- Preparation of narcotics working standard (마약류 표준품 준비)
- Narcotics management master update (마약관리 master 업데이트)
- QC narcotics sample management (QC 마약류 검체 관리)
- Inspection of narcotics storage facilities (QC마약류 저장시설 점검)
- Prepare Exceptional handling of narcotics Protocol and handling completion report
(예외적 마약류 취급 계획서 및 취급 완료 보고서 작성)
ㆍManagement of stability test (안정성시험 관리)
- Protocol, and report etc. (계획서 및 보고서)
- Stability study Schedule management and check progress
(안정성시험 일정 관리 및 진행사항 확인)
- SOP preparation and revision (QC SOP 제정 / 개정)
- Stability study sample management (안정성 시험 검체 관리)
- Stability chamber & room monitoring (안정성 챔버, 안정성 룸 모니터링) |
Job
Requirements |
ㆍMore than 5years-experience in related field
QC 분야에서 5년 이상의 경력
ㆍBachelor's Degree or above, majoring in Chemical or Pharmaceutical.
4년제 대졸, 화학 또는 제약 관련 전공자 우대
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) |
| 채용인원 |
ㆍ0명 |
| 근무지 |
ㆍ향남공장
* 회사의 업무 상황에 따라 변경 가능 |
| 지원방법 |
ㆍ홈페이지 지원 |
| 필수제출서류 |
ㆍ이력서, 자기소개서 |
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| SYSTEM QA Specialist |
지원하기 |
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Job
Description |
ㆍReporting 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.
ㆍContinuously 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
ㆍSite master file management
SMF 관리
ㆍPreparation and management of Product Master File.
제품표준서 작성 및 관리
ㆍReview of Master Batch Record
마스터 제조기록서 검토
ㆍReview of SOP and Attachments
SOP 및 별첨 검토
ㆍGap assessment for regulatory Authority compliance
규제당국 법령 업데이트에 따른 갭 분석
ㆍManagement of Investigation Medicinal Product(IMP)
임상시험용 의약품 관리
ㆍGTIN code management
표준코드 관리
ㆍManagement of Controlled substances
마약류(향정) 의약품 관리
ㆍProofreading and Change control related to Artwork of Label, Carton, Foil, Insert. Etc.
라벨, 카톤, 호일, 설명서 등에 대한 표시자재 교정(RA) 및 변경관리
ㆍSupplier Audit management
공급 업체 평가
ㆍReporting and reviewing of NDMA documents
NDMA 불순물평가 자료 제출
ㆍQUMAS & Compliance wire system management
전자문서시스템/교육관리 시스템 관리 |
Job
Requirements |
ㆍUniversity degree in areas such as Pharmacy, Chemistry, Pharmaceutical Engineering or
equivalent.
- 약학, 화학, 제약공학 또는 이와 동등한 분야의 대학 학위
ㆍProfessional experience – preferably 3 years, of uninterrupted work experience in the
production and/or control of pharmaceuticals.
- 제약회사 3년이상의 경력
ㆍTo 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
ㆍGood communication and English skill, OA skill
- 원활한 커뮤니케이션 및 영어 능력, OA 능력. |
| 계약형태 |
ㆍ정규직 (수습기간 3개월) |
| 채용인원 |
ㆍ0명 |
| 근무지 |
ㆍ향남공장
* 회사의 업무 상황에 따라 변경 가능 |
| 지원방법 |
ㆍ홈페이지 지원 |
| 필수제출서류 |
ㆍ이력서, 자기소개서 |
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| OPERATION QA Specialist |
지원하기 |
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Job
Description |
ㆍDeviation & OOS Management
- Review and support root cause investigation
- Work closely to close the investigation timely manner
- Preparation of deviation trend report
ㆍManagement of CAPA & Change Control
- Review and track of CAPA and Change Control
- Preparation of CAPA trend report
ㆍManagement of Customer complaint
- Receive the complaint and support root cause investigation
- Work closely to close the investigation timely manner
- Preparation of customer complaint trend report
ㆍShop Floor monitoring
- Monitoring of production area & QC lab testing activities
ㆍReview the document related to the operation
- Validation/Qualification) protocol/report
- Batch record review
- Preparation of Product Quality Review
- Preparation of Common Technical Document
ㆍGMP documents review and management
- Preparation and revision of SOPs. |
Job
Requirements |
ㆍPreferred a registered pharmacist in the Republic of Korea(약사 면허 보유자 우대 )
ㆍProfessional experience – preferably more than 7 years, experience in the production
and/or quality department of a pharmaceutical company.
ㆍAbility to manage multiple assignment simultaneously as part of a team.
ㆍGood interpersonal and team skills with ability to build consensus.
ㆍHighly motivated with high personal and ethical standards.
ㆍCross-Functional collaboration for common goal |
| 계약형태 |
ㆍ정규직 (수습기간 3개월) |
| 채용인원 |
ㆍ0명 |
| 근무지 |
ㆍ향남공장
* 회사의 업무 상황에 따라 변경 가능 |
| 지원방법 |
ㆍ홈페이지 지원 |
| 필수제출서류 |
ㆍ이력서, 자기소개서 |
|
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Job
Description |
ㆍManagement of Individual Case Safety Report (ICSR) from all relevant sources
- Report incoming adverse events, Mis, and PQCs to PV CRO and Site Quality/
QA Department (complaints) as applicable.
- Ensures a local tracking system is in place, to ensure timely submissions of adverse events
to PVO/ PV CRO and of ICSRs and Periodic Reports to the Regulatory Authority.
- Completes monthly ICSR reconciliation with interacting departments and/or partner
companies (if applicable) and acts upon any discrepancies.
- Ensures that local processes, procedures and systems are in place for recording,
processing, conducting follow up and translating adverse events and other safety
information reportable to PVO/ PV CRO
ㆍOversight of PV Medical Compliance Risk Management Plan Implementation
- Contributes to the development of local RMP and ensures oversight of its implementation
in collaboration with relevant staff in accordance with Lotus policies and procedures,
global and local regulatory requirements.
ㆍSafety Communications
- Acts as a point of contact for local Health Authorities and ensures communication of
relevant safety information to external key stakeholders as required
- Acts as the key Affiliate contact for internal audits
ㆍManagement of Aggregate Reports
- Provides Safety-related information to PVO and PV CRO for the preparation of
Aggregate Reports as required
- Maintains oversight of submission of PSURs/PBRERs to local regulatory authorities in
accordance with Lotus policies and procedures and local regulatory requirements.
ㆍPV Quality
- Ensures local processes and procedures are in place to clearly define pharmacovigilance
responsibilities within the Affiliate in line with Global SOPs and local regulations.
- Review give input during development of Lotus pharmacovigilance SOPs.
ㆍContract Review and PV Agreements
- Reviews contracts and provides input on necessary clauses/sections/ wording for ensuring
PV medical compliance
- Reviews and approves the safety clauses/sections/wording in local commercial
agreements
- Ensures preparation and execution of PV agreements, as required
- Maintains oversight of PV activities as outlined in PVA |
Job
Requirements |
ㆍBachelor’s degree above (Major: Pharmacy, Nursing, Life Science, etc.) preferred
ㆍMedical/Pharmacovigilance area in Pharmaceutical company or Hospital or Pharmacy
preferred
ㆍ2 or more years of bio-pharmaceutical and/or clinical experience is preferred
ㆍTechnical skills
- Knowledge and expertise in drug development; Product and disease knowledge;
Use of regulations, policies and procedures
- Clear understanding of company policy and the role of pharmacovigilance in business
ㆍManagerial skills
- Strategic focus, Problem-solving, Interpersonal effectiveness, Leading & developing
people
ㆍRequired English Proficiency above Working Confident |
| 계약형태 |
ㆍ정규직 (수습기간 3개월) |
| 채용인원 |
ㆍ0명 |
| 근무지 |
ㆍ서울 강남 본사
* 회사의 업무 상황에 따라 변경 가능 |
| 지원방법 |
ㆍ홈페이지 지원 |
| 필수제출서류 |
ㆍ영문이력서 |
|
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Job
Description |
ㆍAcquire knowledge applicable to products related to each PM’s therapeutic area
(and core products)
ㆍBusiness planning for core product by TA: Market / Competitor / Customer analysis,
SWOT analysis, Segmentation / Targeting / Positioning, Key message development,
Objective, Marketing strategy
ㆍImplementation of creative marketing programs and follow up its results for continuous
improvement
ㆍRegular sales rep training to improve scientific knowledge: Product information &
Key messages, Clinical trials, Market & competitor trend, Customer issue
ㆍMake collaboration with sales team to deliver effective marketing activities
ㆍNew product Introduced feasibility examination and sales forecast
ㆍManagement of medical societies and Drs.
ㆍMain customers management with sales team
ㆍMarketing budget management: Annual budget management by product and account in
yearly plan
ㆍCustomer requests and complaints management: Effective management through the
cooperation of MR and related departments (ex. Product information, NHI guideline,
Quality, Contract, etc.)
ㆍMonthly sales forecast & sales analysis reporting by TA
ㆍFollow code of conduct (CP regulations) |
Job
Requirements |
ㆍMore than 2 years of experience preferably in pharmaceutical industry with relevant
experience in sales & marketing. Especially the working experience in Nephrology.
ㆍUniversity degree above, give preference to related specialty (pharmacy, chemistry, biology)
ㆍCommunication and presentation skill, Leadership skills, MS Excel and Powerpoint skills
required |
| 계약형태 |
ㆍ계약직 |
| 채용인원 |
ㆍ0명 |
| 근무지 |
ㆍ서울 강남 본사
* 회사의 업무 상황에 따라 변경 가능 |
| 지원방법 |
ㆍ홈페이지 지원 |
| 필수제출서류 |
ㆍ이력서, 자기소개서 |
|
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![[알보젠코리아] 각 부문별 신입/경력직 채용](http://www.saraminimage.co.kr/recruit/bbs_recruit9/03_a_img_231218_01.png)
![[알보젠코리아] 각 부문 경력직 채용](http://www.saraminimage.co.kr/recruit/bbs_recruit9/39_alvogenkorea_title_240814.png)
