Junior kontroller állások Külföldön (minőségbiztosítás)

• Support validation activities for equipment, processes, and systems
• Assist in the preparation and execution of validation protocols (IQ/OQ/PQ)
• Review and maintain GMP documentation
• Collaborate with cross-functional teams such as Production, Quality Assurance, and Engineering

• Support and maintain the Quality Management System (QMS)
• Assist with deviations, CAPAs, change controls, training assignments, and quality risk management
• Coordinate governance processes and support inspection readiness activities

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

• Montage (Device Assembly)
• Verpackung (Packaging)
• Du trägst die Verantwortung für eine sichere Arbeitsumgebung und arbeitest sicher; Du bist verantwortlich für die Unterstützung der Gesundheits-, Sicherheits- und Umweltziele des Unternehmens und des Standorts.

Timeliness: Ensure work is completed in a timely manner to support batch release and site priorities....

• 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.

• Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
• Documents incoming inspections in accordance with procedures and specifications.
• Guides Incoming Technicians at the warehouse.
• Coaches and mentors support personnel.

• 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.

You will be a part of the Field Applications Specialist Team and report to the Field Application Manager responsible for providing frontline support by resolving customer(s) problems and issues through technical, scientific expertise and troubleshooting. You will help drive revenue growth while...

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

The role combines two aspects: the Technical Support to Regions (TSR-API), which entails addressing any Regulatory Affairs and Quality Assurance needs that arise in the assigned region (EMEA), and the Technical Support to Manufacturers (TSM-API), which involves acting as the central point of...

• Development new formulations: contribute to design of studies, perform experiments and prepare reports
• Develop analytical methods (e.g. HPLC)
• Prepare and characterize large number of formulations following DOE
• Assist in the development of methods to characterize formulations or raw materials

• 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

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)...

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)...

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• 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

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest.
• Give insights into clinical data sets and evidence for our company's products to internal stakeholders.