Contract, Quality Assurance – Computer System Validation (QA CSV)
Axsome Therapeutics IncSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Enterprise SoftwareIndustries
Requirements
Candidates should possess at least one year of experience in computer software validation specifically for clinical trial software, such as CTMS, CDMS, or eTMF. They must have working knowledge of the software development lifecycle (SDLC) and familiarity with Good Clinical Practice (GCP) guidelines, including 21 CFR Part 11 and EU Annex 11. Exceptional attention to detail and strong interpersonal skills are also required, along with the ability to collaborate effectively.
Responsibilities
As a Computer Software Validation Analyst, the individual will participate in requirement gathering sessions with clients and the RTSM team, collaborate closely with Development and Project Management teams to ensure clear and testable requirements, develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices, manage validation testing cycles and resolve issues, maintain change control documentation, provide technical expertise in computer system validation and quality system requirements, and support customers in RTSM validation activities.
Skills
CSV
Clinical Trial Software
RTSM
Technical Writing
Requirements Gathering
Test Script Development
Change Control
Validation Testing
Risk-Based Testing
Veeva Systems
Quality and regulatory software solutions provider
About Veeva Systems
Veeva Systems offers software solutions for quality, regulatory, and advertising claims management, focusing on consumer products and chemical companies. Their cloud-based platform provides visibility and traceability throughout the product journey, ensuring compliance with regulations and accelerating time-to-market. Unlike competitors, Veeva has specialized expertise in both the Life Sciences and Chemical sectors, allowing them to effectively address industry-specific challenges. The company's goal is to help clients efficiently bring safe and compliant products to market.
Pleasanton, CaliforniaHeadquarters
2007Year Founded
$6.8MTotal Funding
IPOCompany Stage
Enterprise Software, Healthcare, Consumer GoodsIndustries
5,001-10,000Employees