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지원분야
신입 Validation Analyst (Remote)
Veeva Systems Korea와 함께 할 졸업 예정자/기졸업자를 채용중에 있습니다.
임상시험 진행에 필수적인 무작위배정 및 시험약 공급관리 (RTSM, IRT) 소프트웨어 프로젝트에 참여하여, 임상시험 디자인에 맞게 시스템이 구축되었는지 검증하는 절차를 수행하게 됩니다.
검증 절차는 테스트 스크립트를 작성하고 이를 테스트 하는 과정으로 이루어지게 됩니다.
컴퓨터 프로그래밍 스킬보다는 임상시험의 디자인에 대한 이해를 바탕으로 논리적으로 테스트 스크립트를 작성하고 꼼꼼히 테스트 할 수 있는 역량을 요구합니다.
글로벌 팀과 협업하여 프로젝트를 진행할 수 있는 기회 또한 제공합니다.
신입
00명
지원 자격
대졸
전공무관
영어
[자격요건]
•국내외 학사 졸업 예정자 및 졸업자
•업무경력 1년이하 우대
[우대사항]
•Software engineering 또는 QA 업무 경험자
•영어 능력 우수자 (회화 및 독해, 작문 가능자)
•컴퓨터공학과 전공자
[기타 정보]
•영문이력서 제출 (홈페이지 링크 내 지원)
•정규직 채용 (사원급, Validation Analyst, RTSM)
•재택근무 가능
•헬스비용 지원, 임직원 보험 가입, 연 1회 건강검진 제공
•영어 능력 우수자 (회화 및 독해, 작문 가능자)
•IT 관련 업무 경험자
지원서접수
03월 14일 00:00 ~ 04월 30일 00:00
(채용시 조기 마감될 수 있습니다)
영문
[The Role]
We are looking for a Computer Software Validation (CSV) professional with a specialty in clinical trial software. This role would give you the opportunity to work on a leading solution in Randomization and Trial Supply Management (RTSM) software. To excel in this role, you will require strong technical writing capabilities and the ability to simplify complex topics.
As a member of the RTSM team, you will work closely with the Development and Project Management teams to support customer RTSM implementations in a dynamic environment. You will use your expertise to take ownership of the validation process for assigned projects and play an important role in building and maintaining product excellence for the RTSM system.
[What You'll Do]
- Participate in RTSM requirement gathering sessions with clients and RTSM team members
- Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format
- Ensure requirements are adequately tested following a risk-based approach
- Develop and maintain CSV deliverables, including requirements specifications, test scripts, summary reports, and trace matrices
- Manage Validation testing cycles and resolution of issues and enhancement requests
- Maintain change control documentation to ensure ongoing validation of the RTSM system
- Provide technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements
- Support customers as needed in RTSM validation activities
[Requirements]
- 1+ years of experience in a CSV for software
- Working knowledge of software development cycle (SDLC)
- Exceptional attention to detail
- Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels
[Nice to Have]
- Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11
[Perks & Benefits]
- Health & wellness programs
- Charitable Gift Contribution Program
- Monthly Mobile/Internet fee support
