Veeva Systems

Analyst - Computer Software Validation

Veeva Systems  •  Zagreb, HR (Onsite)  •  4 months ago
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Job Description

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.
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 fast-paced 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. This is a remote role with Veeva’s Work Anywhere policy, allowing you to work in an office or at home on any given day. It’s about getting the work done in the way and place that works best for each person.

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+ year of experience in a CSV for clinical trial software (CTMS, CDMS, eTMF, etc.)
  • Working knowledge of software development cycle (SDLC)
  • Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11
  • 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

  • Familiarity with the conduct of clinical trials
  • Previous experience with RTSM
  • Expert in Microsoft Word and Excel
#RemoteCroatia
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
As an equal opportunity employer, Veeva is committed to fostering a culture of inclusion and growing a diverse workforce. Diversity makes us stronger. It comes in many forms. Gender, race, ethnicity, religion, politics, sexual orientation, age, disability and life experience shape us all into unique individuals. We value people for the individuals they are and the contributions they can bring to our teams.
If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com
Veeva Systems

About Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 1,500 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Canada, Europe, Asia, and Latin America. Visit the Jobs section for open positions and remember that correspondence to new applicants and existing candidates will only come from an official @veeva.com email address.

Industry
IT & Software
Company Size
5,001-10,000 employees
Headquarters
Pleasanton, CA
Year Founded
2007
Website
veeva.com
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