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IT Quality Analyst
Company Overview:
Nubilaria is a leader in technological innovation, offering cutting-edge solutions to optimize and enhance business operations.
Join our QA team and gain hands-on experience in digital marketing while shaping the future of our brand and online presence.
Position Overview:
We are seeking a meticulous and proactive IT Quality Analyst to join our team.
This role is pivotal in ensuring that our software products adhere to regulatory standards and quality guidelines, particularly within the clinical trials sector.
If you are detail-oriented, passionate about quality assurance, and eager to evolve into a key quality reference for our product ACTide, this is the opportunity for you!
Responsibilities:
- Plan and review testing and validation processes and documentation in accordance with GCP, GAMP5, and 21 CFR Part 11 guidelines.
- Collaborate with development, product management, and validation teams to ensure quality and compliance throughout the software lifecycle.
- Contribute to the drafting of validation tests and reports to support regulatory compliance.
- Support test automation (where applicable) and continuous improvement of QA processes.
- Identify, report, and track issues and anomalies, monitoring their lifecycle until resolution.
- Assist in internal and external audit processes.
- Participate in supplier qualification.
- Contribute to the analysis of complaints and non-conformities, as well as to the definition of corrective and preventive actions (CAPA).
- Assist in the management, maintenance, and review of the QMS.
Mandatory Requirements:
- At least 2 years of experience in QA or software testing.
- Familiarity with manual testing methodologies and, preferably, automated testing.
- Precision, attention to detail, and a structured approach.
- Strong communication skills and ability to work effectively in cross-functional teams.
- Technical English proficiency (minimum B2 level).
Preferred Requirements:
- Experience in the life science/pharma/medical sector.
- Basic knowledge of relational databases.
- Understanding of GCP guidelines and regulatory requirements for clinical trials.
- Familiarity with ISO 9001, 27001, 14155, 27701 standards.
What We Offer
- The opportunity to work on a mission-critical product used in clinical research worldwide.
- A collaborative, multidisciplinary team focused on quality and innovation.
- Career growth in a regulated, international context.
- Continuous learning on QA best practices, compliance, and technology.