Validation Analyst - RTSM

Veeva

Busan, South Korea3w ago

Free account needed to apply or save. It takes a minute, and we'll bring you right back to this job.

Key details

Location
Busan, South Korea
Work style
Onsite
Level
Mid level
Job type
Full-time
Function
Operations & Strategy
Focus area
other
Posted
3w ago

Skills

21 cfr part 11change controlgcpsdlctechnical writing

About the role

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 $3B 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.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

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 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

  • 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
#LI-Associate

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.

Get jobs like this as soon as they're posted

ApplyHour checks company career sites all day and ranks every opening against your profile. Free to join.

Create a free account