Junior software developer állások Németországban (minőségbiztosítás)

• Du hast zum Zeitpunkt des Praktikums das Studium der Pharmazie mit dem 2. Staatsexamen erfolgreich abgeschlossen.
• Eine sorgfältige und gewissenhafte Arbeitsweise, Zuverlässigkeit und Teamfähigkeit zeichnet dich aus.
• Im Umgang mit MS Office und MS Outlook bist du versiert.

• Lead and support cross-functional projects in regulatory affairs and quality management.
• Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.

Planung und Durchführung von Studien zur Implementierung neuer Methoden, innovativer Technologien und Verbesserung bestehender Methoden in Absprache mit dem Vorgesetzten...

Betreuung, Implementierung und Überprüfung von Maßnahmen zur Qualitätssicherung unter Anwendung der etablierten Q-Systeme. Sie stellen Quality Oversight im Plasmacenter sicher....

Betreuung, Implementierung und Überprüfung von Maßnahmen zur Qualitätssicherung unter Anwendung der etablierten Q-Systeme. Sie stellen Quality Oversight im Plasmacenter sicher....

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

• Regulatory assessment of raw materials, recipes and nutrient profiles
• Creation and updating of regulatory documentation (e.g. list of ingredients, nutrition information, raw material information)
• Review and approval of labels and communication materials in accordance with EU food law

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget

• Leading and advancing chromatographic methods for the characterization of active ingredients, pharmaceuticals, and excipients
• Ensuring robust analytical results with a focus on content determination, degradation products, stability profiles and degradation pathways

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

Subject-Matter Expert (SME) for Test Method Development of delivery devices and combination products: Test Method development, including best practices for universal implementation, Test Method Validation/Transfer....

as part of DFG sponsored project beginning in January 2026 limited for three years. The Title of the project is: EFFECTS OF LACTOBACILLUS REUTERI DSM 17938 ON THE ACUTE PSYCHOLOGICAL, ENDOCRINE AND IMMUNOLOGICAL STRESS RESPONSE IN HEALTHY CITY DWELLERS. Both preclinical and clinical data support...

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Complaint Management and Recall within the EUCAN region.
• Lead the regional standardization and harmonization of Complaint Management and Recall processes, ensuring alignment with GMP and GDP requirements.

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Deviation, CAPA, and OOx within the EUCAN region.
• Drive the standardization and harmonization of these processes at a regional level, ensuring alignment with both GMP and GDP requirements.