Minőségbiztosítási manager 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.

• 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

• 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)

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

_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),...

• 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 and further development of quality standards and processes across all brands of the Huber Group (Huber, Hanro, Skiny, Hom, Gossard)...