QA Validation Specialist

hace 2 semanas

Montevideo, Uruguay Medable A tiempo completo

Company Description
Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.

Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.

**Job Description**:

- Review and approve UAT test scripts to ensure accuracy and completeness
- Review and approve completed UAT test scripts to ensure they are complete and contain objective evidence, as required
- Review and approve validation documentation to ensure it is accurate and complete
- Ensure documentation adheres to the processes and meets required standards
- Review and approve documentation and reports, associated with the validation of products
- Works closely with other departments and functions to promote processes that ensure consistency, continuous improvement, and compliance with quality and business requirements across activities
Provide QA assessment and review of GxP validated systems-related procedures, deviations, CAPAs, and change controls
- Provides guidance/mentoring to junior members of the QA team on less complex issues
- Participate in the continuous improvement and development of Quality Systems to ensure quality and adherence to GxP
- Identify, record, document, and track non-conformity issues
- Manage nonconformity issues and support the development and implementation of solutions
- Review and approve change requests
- Other duties as assigned

**Qualifications**:

- Experience as a Quality Assurance Engineer (preferred)
- Experience writing test scripts
- Experience testing mobile apps, web apps, and APIs
- Experience developing software (preferred)
- Critical thinking and problem-solving skills
- Great interpersonal and communication skills
- Attention to detail
- Flexibility and adaptability on managing/prioritizing multiple tasks
- 4+ years working in Software Development or a combination of education and experience
- Experience working in a GxP environment
- Experience performing validation work to meet 21 CFR Part 11, 21 CFR Part 820, ICH GCP, ISO 13485, and ISO 14971 requirements
**Minimum Level of Education/Preferred Skills**:

- Bachelor’s degree in Computer Science, Engineering, or related field
- Postman, Charles Proxy, Jira, Jmeter, H20, Oracle DB, SQL server, Kobiton, Confluence, Gitlab, Github

LI-REMOTE
LI-MQ1

Additional Information

U.S. employees and contractors, and International workers with travel to the U.S. must have a willingness and ability to provide proof of completed COVID-19 vaccination prior to start date. All strongly held beliefs, religious, medical, and other legally recognized exemptions regarding vaccination status will be considered.

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