Quality Technology Specialist

K-Recruiting Life Sciences; Deutschland; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

K-Recruiting Life Sciences seeks a Quality Technology Specialist (QTS) to provide quality and regulatory technology expertise across ITQA systems and project documentation. The role coordinates with Quality Leads, Validation and IT teams to ensure compliant documentation and testing throughout the project lifecycle.

The QTS supports documentation management, testing/validation activities, and the creation of quality dashboards in Power BI, contributing to governance and continuous improvement

Qualifikationen

• Experience supporting validated IT projects.
• Familiarity with GxP principles.
• Knowledge of CSV concepts desirable.
• Experience with documentation management and document control.

Aufgaben

• Project Support: Coordinate ITQA system and project documentation; support cutover and operational readiness activities; update RAID logs and project trackers.
• Documentation Management: Maintain project, technical, and validation documentation; support templates and version control; prepare documentation packages for review and approval.
• Testing & Validation Support: Prepare validation/testing documentation; review test scripts and cases; organize test evidence and track status.
• Quality Systems Support: Maintain quality and validation documentation; coordinate quality-related records and reports; develop quality dashboards in Power BI.
• Data & Reporting: Gather project data; support planners, trackers, and metrics reporting; monitor actions; support cross-team coordination.

Kenntnisse

Quality Assurance

Regulatory knowledge

Power BI

Documentation management

ALM administration

Project coordination

Tools

ServiceNow

Power BI

Jobbeschreibung

The Quality Technology Specialist (QTS) provides quality and regulatory subject matter expertise related to quality and regulatory technologies. The QTS coordinates across Quality Leads, Validation team members, IT colleagues, and broader cross-functional project teams to align IT Quality Assurance (ITQA) system and project documentation, develop and maintain project records, and assist with testing and validation documentation throughout the project lifecycle.

Key Responsibilities

Project Support

• Support cutover and operational readiness activities.
• Coordinate ITQA system and project documentation.
• Develop and maintain ITQA project records.
• Develop and assist with testing and validation documentation throughout the project lifecycle.
• Update Risk, Assumptions, Issues, and Dependencies (RAID) logs and project trackers.

Documentation Management

• Maintain project, technical, and validation documentation.
• Ensure templates and reference documents are used consistently.
• Support version control and document repositories.
• Prepare documentation packages for review and approval.

Testing & Validation Support

• Support preparation of validation and testing documentation.
• Support Application Lifecycle Management (ALM) administration activities.
• Review test scripts and test cases for completeness against agreed templates.
• Organize test evidence and supporting documentation.
• Track review and approval status.

Quality Systems Support

• Support maintenance of technical and validation documentation.
• Assist with quality system governance activities.
• Coordinate quality-related records and reports.
• Assist with periodic reviews and governance documentation.
• Develop and maintain quality reports and dashboards in Power BI.

Data & Reporting

• Gather project and operational data from multiple stakeholders.
• Provide input into project planners, trackers, and support project metrics reporting.
• Monitor completion of assigned actions and follow up where required.
• Support planning and coordination activities across Quality, Validation, and IT teams.
• Experience supporting Quality Assurance, Validation, or regulated projects.
• Basic understanding of GxP principles and quality management systems.
• Experience with technical or validation documentation.
• Experience with documentation management and document control.
• Experience developing and maintaining Power BI reports and dashboards.
• Knowledge of Computer System Validation (CSV) concepts (desirable).
• Familiarity with GAMP 5 principles and the validation lifecycle (desirable).
• Experience using ALM, ServiceNow, or similar project management/testing tools (desirable).
• Experience supporting ERP, digital transformation, or technology implementation projects (desirable).
• Experience working in a matrix or global project environment (desirable).