Validation Analyst - RTSM (Remote)

Fortune 50 글로벌 소프트웨어사 Veeva는 실리콘밸리에 본사를 둔 클라우드 SaaS 회사로써 R&D 에서 커머셜에 이르는 모든 분야에서 고객의 가장 중요한 기능을 지원할 수 있도록 데이터, 소프트웨어, 서비스, 컨설팅 및 광범위한 파트너 에코 시스템을 제공하고 있습니다. 포춘지에서 가장 빠르게 성장하는 회사로 선정된 바 있으며 2006년부터 현재까지 LG, 삼성과 같은 고객들과 함께 글로벌 제약시장을 이끌고 있습니다.
Veeva Korea 홈페이지 방문하여 디지털 엑설런스 알아보기: https://www.veeva.com/kr/

비바와 함께하실 Validation Analyst를 채용중입니다. (※홈페이지 지원: https://careers.veeva.com/job/09cd6c31-e080-4a70-a799-5918b8a13cce/validation-analyst-rtsm-seoul-south-korea/?lever-source=veeva-career-site) 이 포지션 재택근무 가능합니다.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We’re not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

#외국계 #IT #SaaS #클라우드 #생명과학 #클라우드솔루션 #CSV #Computer Software Validation #QA Engineer #Software Engineer #RTSM ​

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:

● Work anywhere policy
● Allocations for Continuous Learning & Development
● Allocations for Health and Fitness
● Allocations for Charitable Giving Programs