Quality controller állások Németországban (egészségügy, gyógyszeripar)

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

• Plan and perform GMP/GDP Audits at Contract Manufacturing Organizations (CMOs) or Suppliers
• Prepare audit findings & reports and discuss potential impact on business

In the position as _Global Head of Quality_ you will lead a global Quality organization and define productcentric quality strategies for established products, ensuring integration, lifecycle management, and reliable supply. You drive consistent execution and continuous improvement by embedding...

• Analyze existing business processes related to GxP document management in the EUCAN region.
• Collaborate closely with the System Owner and QA Systems representatives to develop a comprehensive migration strategy into the eDMS.

• Lead quality oversight activities at CMOs to ensure compliance with Daiichi Sankyo standards and international GMP guidelines
• Support and manage quality topics such as change control, deviations, and complaints related to Daiichi Sankyo products

• Author and revise Standard Operating Procedures (SOPs) and quality system documentation in line with ISO 13485 and EU MDR 2017/745 requirements.
• Conduct GAP analyses of the QMS to identify compliance gaps and support continuous improvement activities.

• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

• Ensure, develop and continuously improve the Quality Management System in compliance with ISO 9001, ISO 15378 and ideally ISO 13485
• Define, implement and monitor quality objectives and KPIs to drive sustainable improvement of products and processes

• Ensuring compliance with applicable medical device software regulations and standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366 and IVDR
• Defining, maintaining, and governing software-related quality policies, procedures, SOPs, templates and lifecycle frameworks

The job of the _Senior Quality Product Owner_ is to provide end-to-end ownership of all quality product-related activities, ensuring a strong product strategy that supports compliance, product availability, and patient safety throughout the entire product lifecycle, while enabling transparent and...

In the role as _Global Head of Quality Systems_, you ensure a robust and compliant Quality Management System that is fully process-based and supported by integrated IT system solutions across all GxP areas (GMP, GVP, GCP). You lead CP quality interfaces, system architecture, and data integrity...

• Define clinical and technical requirements for online eye testing and centration
• Understand limitations and barriers and lead mitigation
• Drive product development and user validation
• Serve as interface between optometry experts, engineers and business units

• Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs
• Preparation, review, and approval of all relevant study documents in collaboration with external service providers

• Stay up to date and share information with team and clients regarding regulatory changes that impact food safety
• Communicate complex technical information internally and externally to a wide range of audiences (technical and non-technical)

The position as QC Bioassay Manager is responsible for leading a team of seven employees within the Quality Control department of AGC Biologics Heidelberg. This role entails the management and oversight of analytical testing of Bioassay Methods for Proteins and Nucleic Acids, including PCR, ELISA,...