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| 글로벌 헬스케어사 QA Associate Manager 채용 (지원마감) | |
|---|---|
| 회사소개 | 글로벌 헬스케어 기업 |
| 업무내용 / 자격요건 |
[담당업무] OVERVIEW (SUMMARY) QMS Implementation and maintenance for marketed products (Drug, General Cosmetics, Medical devices) in accordance with all applicable Korean regulations. This position has main responsibilities in post-market management for healthcare products registered under ZPTx and Clients. ROLES AND RESPONBILITIES ? Regional QMS point of contact ? QMS (Quality Management System) improvement and simplification for ZPTx using tools of Deviation, CAPA, RCA, Risk management on issues occurred during daily working and Oversight local QMS established to ensure compliant ZPTx operations to meet both regulatory and customers’ expectations. This includes harmonizing the quality standards and simplifying processes whiles driving both compliance and efficiency ? Manage Batch release for the subject products (Drug, General Cosmetics, Medical Devices and/or Foods) which are registered under ZPTx and/or Clients in accordance with all applicable Korean regulations ? Quality governance and Risk management including DMS (Document Management System) and ISO9001;2015 certification and maintenance. Own and implement Regional Quality system and processes, if applicable ? Manage training relevant to Quality matters in a timely manner as per requirement ? Oversight of quality performance for Local 3rd party contracted La. for local QC testing and standard materials for Drug in line with Batch release and relevant Tech transfer from manufacturing sites, if applicable ? Collaborate with other Quality teams in ZP Korea and Regional ZPTx to promote sharing and learning and to align quality policies as one ZP ? Manage GMP certification for Medical Devices & on-site audit ? Conduct Internal and manage external audit/inspection and due diligence by competent authorities and clients ? Partner with Supply Chain and ensure significant 3rd party related risks are appropriately escalated and mitigated in a consistent manner KEY PERFORMANCE INDICATORS ? Financial KPI of Team OP Achievement ? Existing Business Support by managing Current Business ? Support for New Business ? Support for Regional Quality team QUALIFICATION ? Education : Bachelor’s degree or above (major in pharmacy, science, an engineering discipline, biology, or equivalent level of knowledge, understanding and hand on experience of Good Manufacturing Practices in the pharmaceutical environment) ? Language : Fluent in English in written and verbal communication ? Technical : Must be computer literate ? Experience : - 5 years’ of regulatory/manufacturing/quality experience in the pharmaceutical or medical device industry at least - Experience of audit by regulatory competent and regulatory audit by corporate - Experience of batch release in manufacturing sites or importing companies. COMPETENCIES REQUIRED ? Ability to work independently and prioritize workload. ? Excellent oral and written communication skills ? Strong interpersonal skills with an ability to enable and drive change. ? Problem identification and solving skills ? Experience of working with multi-functional teams. ? Great toward of Collaboration/Innovation/Integrity and trust/Passion for Excellence/Personal Growth [자격요건] QUALIFICATION ? Education : Bachelor’s degree or above (major in pharmacy, science, an engineering discipline, biology, or equivalent level of knowledge, understanding and hand on experience of Good Manufacturing Practices in the pharmaceutical environment) ? Language : Fluent in English in written and verbal communication ? Technical : Must be computer literate ? Experience : - 5 years’ of regulatory/manufacturing/quality experience in the pharmaceutical or medical device industry at least - Experience of audit by regulatory competent and regulatory audit by corporate - Experience of batch release in manufacturing sites or importing companies. COMPETENCIES REQUIRED ? Ability to work independently and prioritize workload. ? Excellent oral and written communication skills ? Strong interpersonal skills with an ability to enable and drive change. ? Problem identification and solving skills ? Experience of working with multi-functional teams. ? Great toward of Collaboration/Innovation/Integrity and trust/Passion for Excellence/Personal Growth [전형절차] 서류전형 - 컨설턴트 인터뷰 - 기업 면접 [제출서류] 국문이력서(경력기술서 포함) [직무분야] QA [경력년수] 5년 이상 [기본연봉] 면접 후 협의 [참고사항] ? Employment type : Permanent [지원방법] 하단의 회원 온라인지원 혹은 ap@cnscout.co.kr 로 이력서를 보내 주시면 검토 후 헤드헌팅을 진행하여 드리겠습니다. |
| 기타사항 |
학력:대졸이상, 외국어:무관 직급/직책:면접 후 협의 근무지:서울 용산 |
| 담당자 |
담당컨설턴트: 박주연 컨설턴트 연락처: 02-782-9409 / 이메일: ap@cnscout.co.kr |
