• Organization Fit
• • Report to Astellas Korea QA Team Leader
• Essential Job Responsibilities
• • Release approval of Pharmaceuticals as a registered pharmacist
• - Ensuring product meets specification and the local requirements prior to release
• - QC test management (checking samples and reviewing QC data, etc.)
• • Manage package materials with local regulation
• - Check that package materials of imported products are up to date
• - Prepare and proceed with relabeling the package materials if necessary
• • Communicate and manage the QA related contract company (laboratory & warehouse, etc.)
• • Document Management
• - Ensure compliance with the local regulation and Astellas global SOP
• - Prepare Product Master File according to change of product license
• • Perform an Annual Product Quality Review
• • Handling of Quality Issue (Deviation, Compliant and CAPA, etc.)
• • Other QA activities
• - Perform Periodic self-inspection for relevant local departments and warehouse
• - Support analytical method transfer
• - Support Product license Renewal
• Knowledge, Experience, and Abilities Require
• • Knowledge on the relevant laws, regulations and guideline (GMP and GDP) in pharmaceutical industry
• • Established career in the pharmaceutical industry in QA, and relevant field
• • Good understanding on the analytical test method and result.
• • Effective communication and cooperation with stakeholders
• • A strong commitment to integrity and professionalism and a commitment to excellence.
• • Competent English skill

• Qualifications
• • License of pharmacist in Korea (Mandatory)
• • More than 3 years’ experience in QC/QA field in pharmaceutical industry (Preferred)

• [기본]
  ▸ 자격증 사본(해당자에 한함)
• ▸ 국가보훈대상자는 취업지원 대상자 증명서 제출
• ▸ 장애인 대상자는 장애인 증명서 제출
• [필수] ▸ 최종학교 졸업증명서 및 성적 증명서
• [필수] ▸ 이력서에 기입 된 재직(경력)증명서 전체
• [필수] ▸ 영문 CV

※제출서류는 지원서 제출시 첨부파일로 제출

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