Junior software developer állás, munka

Kapcsolattartás a vevőkkel termékminőségi problémák esetén; Beérkező minőségügyi reklamációk kezelése; Hibaanalízis készítése ismert hibaanalitikai eszközökkel (pl. 8D, Pareto, 5Why, Ishikawa, PFMEA); Helyesbítő és megelőző intézkedések bevezetésében való részvétel és nyomon követés; Együttműködés...

• Start Date: asap
• Latest Start: February 2026
• Planned Duration: 9-month maternity cover
• Extension: possible
• Location: Basel
• Workload: 100%
• Home Office: 2 days/week after 2-3 months onboarding
• Travel: none
• Team Size: 6 people
• Template Used: CH_Real World Data Scientist_LSW_CHF_RCM_CO

• 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...

• 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.

• Perform analyses of finished products, samples in progress, raw materials, excipients, cleaning samples, validations and environmental monitoring according to established procedures.
• Ensure the maintenance and proper functioning of the BCQC laboratory equipment.

Act as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Change Control and Risk Management within the EUCAN region....

• 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.

• You ensure that each batch is manufactured and tested in accordance with legal regulations
• You approve or reject bulk and finished products and sign the corresponding test protocols
• You approve specifications, sampling instructions, and testing instructions and ensure compliance with them

• 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).