Termékellenőr állások, munkák Németországban

• 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.

• 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.

• 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

• 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.

Unterstützung der Parenteral Operations durch Durchführung des Umgebungsmonitorings (Environmental Monitoring - EM) in klassifizierten Produktions- und Abfüllbereichen sowie Probenahme/Analyse von Versorgungsanlagen innerhalb der Parenteral Operations und QC-Laborgebäude....

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

Management of regional and local Quality & HSE Team and activities as well as implementation of group-wide initiatives and projects, including qualification and personnel development...

• Develop and implement quality management strategies and policies to ensure compliance with industry standards and regulations.
• Develop the company's Quality Management System to ensure it conforms with the customer, ISO 9001, ISO 14001, IATF16949, and regulatory/legal requirements.

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

• Guiding and supporting your team by overcoming roadblocks and exceeding expectations
• Ensuring appropriate staffing for all active Simultaneous Development Teams (SDTs) in collaboration with Program Management and Quality leadership

• Manage and monitor supplier quality performance to ensure compliance with company standards
• Conduct supplier audits and assessments to evaluate manufacturing and quality systems
• Handle supplier quality issues and drive root cause analysis and corrective actions

_Ensure compliance with automotive standards such as IATF 16949, VDA, and OEM-specific requirements_ _Support the process team to create and maintain process documentation including SOPs, work instructions, PFMEA, control plans, and process flow diagrams_ _Support new product introductions (NPI),...