Minõségellenõrzõ operátor állások, munkák Németországban

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...

• 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)...

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Set up test systems (hardware / virtualized) in complex network structures so that they are ready to perform test cases
• Set up and run tests in line with test specifications and take appropriate actions (i.e. passing the test, raising a defect)

• Ensure each site supports effective CAPA implementation and continuous improvement.
• Lead the CAPA Review Board to drive alignment with quality goals and expectations across the organization.

• 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

Build and Empower: Take full ownership of the Quality Assurance team. You will be responsible for structuring the department, hiring specialists, and fostering a culture of precision and excellence from the ground up....

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

• Lead the development and consistent application of technical risk management processes (FMEA: DFMEA, SFMEA, PFMEA) across all project phases.
• Drive digitalization of risk management through tools like cloud-based FMEA platforms, dashboards, and automated tracking systems.

• Lead global manufacturing quality strategy, ensuring alignment with Voith Hydro's renewable energy objectives.
• Ensure quality oversight across diverse manufacturing processes, with a strong focus on turbine and generator fabrication.

• Review customer specifications and legal/statutory requirements, ensuring compliance with Voith Hydro standards and EQM guidelines.
• Prepare and issue project-specific Quality Plans and documentation (e.g., Inspection & Test Plans, QS, MGS).

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams