Advanced Quality Specialist (GxP) for our Application Lifecycle Management

Advanced Quality Specialist (GxP) for our Application Lifecycle Management (ALM) Team

Profile Summary
The Advanced Quality Specialist is responsible for ensuring the quality and compliance of the ALM Quality Center software, The Advanced Quality Specialist will perform various tasks related to validation, testing, release management, support, audit, training, and presales of ALM Quality Center services. The Advanced Quality Specialist will also be the trainer on ALM Quality Center for users and customers.

Responsibilities
The ideal candidate possesses the following qualifications and experience:

• Creation of Training material, conduct user training inhouse and for customers, 3. Level support.
• Quality, Planning, Validation Planning, GxP impact assessments, IQ/OQ/PQ protocols & reports.
• Testing and documentation based on GAMP5 and FDA compliance. Validation and Compliance Quality Control according to the V-model. This includes Quality Planning, Validation Planning, GxP impact assessments.
• Handles Minor and Major releases/changes within Computer System Validation (CSV).
• Managing scope of Tests, creation of Test Plans/Protocols and Reports.
• Defect/Deviation handling.
• Design and execution of Test for minor and major releases of ALM Quality Center.
• Technical and Functional Support – 3rd level support of ALM Quality Center.
• Participate in Customer Audit’s.
• Responsible for the ALM Quality Center validation presentation and handling of questions in Customer Audits.
• Customer presentation of ALM Quality Center including Technical and functional Demo of ALM Quality Center.

Qualifications

• Bachelor's degree or equivalent in computer science, engineering, or related field.
• At least 3 years of experience in quality assurance, validation, testing, or support of software systems in a regulated environment.
• Knowledge of GxP, GAMP5, FDA, and CSV requirements and standards.
• Preferably experienced in test management, test design, and test execution.
• Preferably experienced in ALM Quality Center or similar tools.
• Excellent communication, presentation, and interpersonal skills.
• Ability to work independently and as part of a team.
• Ability to learn new technologies and processes quickly.

Please note that we will be evaluating applications and inviting candidates for interviews on an ongoing basis.

About Aeven and Automation, AI & Tools Team
At Aeven, we are driven by a mission to safeguard and enhance the digital infrastructure that is essential to the lives of millions. To achieve this, we are on the lookout for individuals with sharp minds, capable hands, and, most importantly, positive personalities that thrive on collaboration, contribution, skill development, and making a meaningful impact.

Aeven's Automation, AI & Tools division is at the forefront of delivering a comprehensive suite of integrated technologies encompassing Infrastructure Automation, RPA, Application Lifecycle Management (ALM), Monitoring, ITSM, and CMDB. With an extensive portfolio that combines enterprise-grade solutions and in-house innovations, we facilitate Aeven's growth journey, offering both traditional on-prem infrastructure and application outsourcing as well as hybrid cloud services.

The Application Lifecycle Management team helps organizations to manage and structure the Application Lifecycle from Project Planning, through Requirement gathering, Tests, Deviations/Error handling to Production.

Department: Østmarken 3a, Søborg

Lokation: Copenhagen