Program állások Németországban (egészségügy, gyógyszeripar)

• 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

• Upstream processing in the field of viral vectors / ATMPs
• Establishment of cell and virus banks
• Implementation and optimisation of seed trains
• Production of viral products and/or ATMPs up to a scale of 200 litres

• 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.

Provides medical input to Clinical Trial Protocol, Investigator's Brochure, Informed Consent Form, Independent Data Monitoring Committee Charter, Statistical Analysis Plan, Medical Monitoring Plan, Clinical Trial Report, Clinical Trial Overview Statements and other clinical trial documents...

• 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

• They support the team in the calibration laboratory in processing customer orders.
• They perform calibration services, maintenance and repairs as instructed.
• They provide support in handling complaints.
• They prepare cost estimates for customers.

• Coordination of the large, international, and interdisciplinary MEDAL research consortium
• Content-related preparation, planning, and coordination of appointments, meetings, and events
• Attending and assisting with appointments and committee meetings, as well as their preparation and follow-up

• 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

Support the country's LT in the development and execution of multi-year strategic account plans tailored to customer needs; co-creating solutions and value propositions that elevate customer relationships....

Working independently in the areas of valve crimping, case management, pre-case planning, post-case management, 3 Mensio management, Therapy Awareness program management and clinical education programs...

HOW YOU WILL MAKE AN IMPACT • Provide education on all aspects on one technology of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants including full certification for independent case support • Educate and...