For Candidates
개인회원
- HOME
- For Candidates
- 채용정보 전체검색
채용정보 전체검색
| 외국계 헬스케어사 QA Manager 채용(계약직, 15개월) | |
|---|---|
| 회사소개 | 글로벌 헬스케어 기업 |
| 업무내용 / 자격요건 |
[담당업무] [OVERVIEW] QMS Implementation and maintenance for marketed products in accordance with all applicable Korean regulations and Zullig Pharma internal policies. This position has main responsibilities in post-market management across all relevant area to ensure good product quality for healthcare products registered under ZPT Korea. [ROLES AND RESPONSIBILITIES] - Participate in regional meetings held regularly as a Regional QMS point of contact - QMS (Quality Management System) improvement and simplification for ZPT using tools of Complaint, Deviation, CAPA, RCA, Risk management on issues occurred during daily working and Oversight local QMS like change control, established to ensure compliant ZPT 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 Drug products which are registered under ZPT and/or Clients in accordance with all applicable Korean regulations - Quality governance and Risk management including DMS (Document Management System) and ISO9001;2015 certification. Own and implement Regional Quality system and processes, if applicable - Manage training relevant to Quality matters in a timely manner as per requirement and ZP Academy System - Allocate quality annual training plan and monitor planned training completion as per the annual plan - Oversight of quality performance for Local 3rd party contracted Lab. for local QC testing and standard materials for Drug in line with Batch release - New product launch readiness Technical Transfer - Coordinating analytical method technical transfer - Cooperate with Sending Unit (SU) and Receiving Unit (RU) to keep the timeline of the technical transfer - Coordinate import of all the required materials (reference standards, reagents and samples) by preparing the required documents depend on its origin - Review the protocol and the report for analytical method transfer - If necessary, manage purchasing equipment, Setting first QC release test - Review test method SOPs - Transfer the related documents and retention samples, if necessary - Collaborate with other Quality teams in ZP Korea and Regional ZPT to promote sharing and learning and to align quality policies as one ZP - Managing on-site/virtual GMP inspection by communicating with MFDS and overseas manufacturing site - Conduct Internal and manage external audit/inspection and due diligence by competent authorities and clients - Conduct supplier quality management - Partner with Supply Chain and ensure significant 3rd party related risks are appropriately escalated and mitigated in a consistent manner - Introduce Electronic Quality Management System module (eQMS) - Prepare the Annual Product Quality Review (APQR) - Prepare and/or Review the QA Agreement (QAA) [KEY PERFORMANCE INDICATORS (KPIs)] - Financial KPI of Team OP Achievement - Maintain post-market activities and procedures with compliance for success of Existing Business - Support relevant resources for New Business development - Support local quality matters in line with Regional Quality projects [국문요약버전] 1. QMS 업무, 관리(CAPA, RCA, Risk Management 등) 2. ZPT/고객사에 등록된 의약품 관련 모든 한국 규정 준수 및 출하 관리 3. DMS 및 ISO9001 인증 포함한 품질 거버넌스 및 리스크 관리 수행 4. Quality 기준에 따른 의약품 품질관리 [자격요건] [QUALIFICATIONS] * 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 -7 years’ of regulatory/manufacturing/quality experience in the pharmaceutical or medical device industry at least - Knowledge about pharmaceutical regulation and quality assurance system - Experience of audit by regulatory competent and regulatory audit by corporate - Experience of batch release in manufacturing sites or importing companies - Experience of working in MNC companies - Experience of working in Drug, General Cosmetics, Medical Devices and/or Foods industries is preferred [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. - Excellence in Word, Excel, PowerPoint - Great toward of Collaboration/Innovation/Integrity and trust/Passion for Excellence/Personal Growth [국문요약버전] - 학사학위 이상(제약 과학, 공학, 생물학 등 관련학과) - 제약 또는 의료기기 산업에서 최소 5-7년 이상의 규제, 제조 또는 품질 관련 경력 보유 - 의약품 관련 규정 및 품질 보증 시스템에 대한 지식 보유 - 규제 당국 및 기업 내부 감사 경험 보유 - 비지니스 영어 중상급 이상 - 우수한 컴퓨터 활용 역량(Excel, Word, Outlook, Power point) [전형절차] 서류전형 - 컨설턴트 인터뷰 - 기업 면접 [제출서류] 국문이력서(경력기술서 포함) [직무분야] QA [경력년수] 5년 이상 [기본연봉] 면접 후 협의 [참고사항] Fixed-term (15 months / Replacement for Parental Leave) [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:Manager 근무지:서울 |
| 담당자 |
담당컨설턴트: 박주연 컨설턴트 연락처: 02-782-9409 / 이메일: ap@cnscout.co.kr |
