한국에자이 PDM QA 채용 (~ 2/28 마감)

[HR팀]

한국에자이 PDM QA 채용 (~ 2/28 마감)

한국에자이는 글로벌 헬스케어 기업 에자이 (Eisai) 의 한국법인입니다. 국내에 우수전문의약품을 소개하면서 Neurology & Oncology 및 Critical Care 분야의 시장을 선도하고 있습니다. 환자들이 존중 받으며 치료받고, 더 나은 삶을 영위할 수 있도록 의약품 개발과 헬스케어 솔루션 창출에 최선을 다하고 있습니다. hhc (human health care) 철학과 혁신적 사고 중심으로 지속적인 환자 베네핏 창출을 통해 더 나은 세상을 만들고자 하는 비전을 지닌 “MEDICO SOCIETAL INNOVATOR” 여러분의 많은 지원을 기다립니다!

[모집분야 / 근무조건]

• QA Supervisor, Experienced or Associate (to be determined depending on applicant)

 - 약사 면허 필수
 - 근무조건: 계약직(연장검토 가능)
 - 근무지역: 한국에자이 분당사무실

[Job Requirements] 

• Job-specific requirement 
  - In total 1~8 years’ experience in pharma industry with at least 1 year experience of RA or GMP
  - Direct or indirect RA and/or pricing experience (preferred)

• Competency and knowledge
  - Expert knowledge, understanding and application of principles, concepts and practices of government regulations.
  - MS office (Excel, Powerpoint, Word) skills
  - Fluency in English

[Key Responsibilities] 

• Job Summary 
  - Support the maintenance of the quality management system by continuous improvement complied with Korean regulations and Eisai standards.
  - QA control of all products fulfill the requirements and ensures quality control in the warehouses in order to meet the requirements in accordance with Korean pharmaceutical affairs law and regulations.

• Responsibilities
  - Supports the maintenance and implementation of Quality Management System (QMS) with continuous improvement (Quality Complaint, Recall, Deviation, Change Control, Investigation, CAPAs, Training, Self-inspection)
  - Manages the supply of reference standards & testing samples to support local testing
  - Performs sampling for QC test and retention sample
  - Manages the warehouse environment in accordance with relevant regulation
  - Performs Validation and Qualification for warehouse.
  - Performs incoming inspection and verifies incoming product documents including packing list and CoAs.
  - Manages and eval‎uates out-sourced activities on CMOs, contract laboratories, 3rd party warehouses, transportation and, etc. (Audit and Quality Agreement)
  - Establishes and maintains local GxP SOPs in accordance with document control SOP
  - Prepares and manages Health Authority inspection and suppliers’ audit as an auditee(host) and takes required actions.
  - Generates annual product quality review documents for imported products in accordance with GIP regulation. 
  - Ensures that controlled drugs are stored in safe, dedicated and secure areas according to the relevant regulation requirements
  - Facilitates re-sticker, re-label process

[공통지원자격] 

• 국가보훈대상자는 관계법령에 의거 우대 

[전형방법] 

1차 서류전형 (온라인지원, https://eisaikorea.recruiter.co.kr/) 2020년 2월 28일(금) 23:59 까지
2차 면접전형 (서류전형 합격자에 한해서 추후 통보) - 2020년 3월 중 예정
3차 최종합격 및 신체검사
          ▷ 각 전형의 합격자는 개별 통보 합니다
          ▷ 면접에 참석해 주신 지원자에게는 소정의 면접비를 지급합니다. 

[복리후생] 

• Flexible time 제도 
• 건강검진 / 단체보험 등 업무 관련 비용 및 복리후생 지급
• 각종 경조금 지급 / 안식휴가 여행지원금 지급 등

핫한 취업뽀개기 게시판 보고 취업에 한걸음 더!