Program állások, munkák minőségbiztosítás kategóriában

• Alkatrészek sorozatkísérő tesztelése és mérése (Zeiss Caligo, Eagle EYE)
• A mérési eredmények minőségi, mennyiségi és határidő szerinti ellenőrzése
• Mérési folyamatok és eljárások elemzése és optimalizálása
• Mérési elemzések és sorozatok, DoE mérési tesztek végrehajtása és dokumentálása

Monitors CSR’s performance on a daily basis, by taping, listening to, reviewing and evaluating calls...

• Support legal and compliance activities across ONPG
• Monitor adherence to internal Standard Operating Procedures (SOPs) and relevant pharmaceutical laws and regulations
• Maintain and continuously improve ONPG's contract database

• Performing microbiological methods, including aseptic work under a safety cabinet, in accordance with test instructions/protocols
• Conducting microbiological monitoring in cleanrooms and laboratories, as well as monitoring media such as water and process gases

Ensure compliance with company policies, regulatory requirements, and ISO/IEC 17025 accreditation standard while maintaining accreditation credentials....

• Downstream processing in the field of viral vectors / ATMPs
• Carrying out filtration and chromatography
• Qualification and execution of aseptic manufacturing processes for non-filterable active pharmaceutical ingredients
• Work in cleanrooms up to hygiene zone B

• Coordinate with wet laboratories, contract research organizations (CROs), and external collaborators to facilitate the transfer of imaging data and associated metadata.
• Ensure incoming datasets are delivered according to defined data formats, metadata standards, and project requirements.

• Provide direct line management for >10 CP Delivery Managers embedded across drug programs and AI/ML model development initiatives
• Build delivery capability through coaching, role clarity, performance management, and career development

• Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations.
• Confirms batches of products intended for clinical trials.

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

• Montage (Device Assembly)
• Verpackung (Packaging)
• Unterstütze den Start und den Routinebetrieb der QA-Organisation, die die DAP-Aktivitäten am neuen Hightech-Pharma-Produktionsstandort von Lilly in Alzey, Deutschland, überwacht.

• Vorbereitung von Materialien/Geräten
• Formulierung und aseptische Abfüllung
• Visuelle Inspektion
• Sorge für ein sicheres Arbeitsumfeld und sicheres Arbeiten; unterstütze alle Gesundheits-, Sicherheits- und Umweltziele des Unternehmens und des Standorts.

• Planning, writing, reviewing and submitting manuscripts on clinical drug trials in humans for peer-reviewed journals and abstracts for scientific conferences
• Data visualization of data from clinical drug trials
• Supporting preparation of posters and conference presentations

Scientific oversight and coordination of preclinical and toxicology studies conducted in collaboration with CROs, academic partners, and scientific institutions - covering both GLP-regulated and exploratory/non‑GLP research...