국민대학교

사노피-아벤티스 / http://www.sanofi.co.kr/ / 1991년 설립 / 500명 이상
주소: 서울시 서초구 반포동 63-7 (3, 7, 9호선 고속터미널역 5번 출구 부근)
계열사: ㈜사노피-아벤티스 코리아, 사노피 파스퇴르㈜, 오펠라헬스케어 코리아

[근무회사 및 모집부문]
* 근무회사: 고속터미널역에 위치한 프랑스계 글로벌 제약회사
* 사업분야: 전문 의약품, 헬스케어, 백신, 의료기기 등
* 모집부문: Quality Associate
* 특이사항: 중식, 초과근무 수당, 선택적 복리후생비, 영어교육비 별도 제공
[회사소개]
- 프랑스에 본사를 둔 세계 선두의 헬스케어 기업으로, 국내에서는 전문의약품 및 건강기능식품을 공급하고 있으며, 이 외에도 백신, 희귀질환치료제를 통해 예방에서 치료까지, 환자들의 다양한 니즈에 부응하는 통합적인 헬스케어 기업으로 자리매김 하고 있습니다.

[업무내용]

Purpose : Provide support to ensure that affiliate operations are conducted to an adequate level of quality system in conformity with regulatory and internally defined standards.

<Quality System>
1. Quality Document management

(1) Local QD Management
- Up-to-date local quality QD list maintenance through regular monitoring
- Prepare and monitor local quality QD plan and report.
- Assess the assigned QD and mitigate the gap accordingly.

(2) Electronic Document Management System management (Geode+ & Gibraltar & Veeva)
- Local focal point and local user access management (user training, access grant coordination, annual local access review, and so on)

2. GxP document and record management

(1) Monitoring quality document inventory list and performing periodic reviews.
(2) Control the access to the office archiving room and perform an annual access review.
(3) Coordinate transfer/retrieval/destruction of a paper document and record to IMK (External document archiving party)(4) Handwritten and electronic signature management (including Adobe GxP e-sign system access and reconciliation coordination) 

3. Training (1) Manage and monitor GxP training matrix to be updated in a timely manner by each country GxP functions.
(2) Prepare a quality annual training plan and monitor planned training completion as per the annual plan.
(3) Coordinate quality individual training plan to be established according to GxP training matrix.)

4. Change Control : Change Control process and system (Phenix, Veeva) management.

5.  Deviation and CAPA : Event and CAPA process and system (Phenix, Veeva) management 

6.  HA Inspection & Country GxP Audit
(1) Provide support for IRT Exercise (notification, data gathering, and so on)
(2) Provide Support for inspection preparation & coordination.

< New Product Introduction >
1. Support pre-approval GMP inspection.
2. Support Analytical Method Transfer and first QC release test setting.

**자세한 JD는 이메일 문의 시 추가 공유드릴 예정입니다.

[지원자격]Education

• Bachelor’s degree or above in science
• Pharmacist is preferred.

Experience & knowledge

• At least 3 years experiences in the pharmaceutical industries
• Knowledge about pharmaceutical regulation and quality assurance system

Core competencies /skills

• English/Korean proficiency is essential.
• Project management skills and cross-functional competence
• Presentation skills and strong communication skills
• Excellence in Word, Excel, PowerPoint

[근무환경]- 계약기간: 1년 (파견계약직, 계약 연장 가능성 있음)- 근무지: 서울시 서초구 반포동 (3, 7, 9호선 고속터미널역 5번 출구 부근 / 재택 병행)- 근무시간: 09:00 ~ 18:00 (주 5일 근무)
- 급여: 회사 내규 (경력직의 경우 경력년수 및 최종연봉에 따른 차등 지급)
- 특이사항: 성과급, 중식, 초과근무 수당, 선택적 복리후생비, 영어교육비 별도 제공

[지원방법]
- 온라인 접수 링크 : https://manpowergroupkorea.ninehire.site/job_posting/Wckz12AT
- 제출서류: 국문 이력서 및 자기소개서 (MS Word 양식)
- 담당자: 이혜지 대리, 02-6420-0364