It üzleti tanácsadó állások, munkák minőségbiztosítás kategóriában

• Vizsgálatra érkező minták kromatográfiás (HPLC) vizsgálata az érvényes külső és belső előírások szerint
• Anyagvizsgálatokhoz kapcsolódó teendők ellátása (oldatok készítése, mérőoldatok faktorozása)
• Vizsgálatok eredményéről a dokumentációk készítése (mérési jegyzőkönyvek vagy munkafüzetek)

Lead the implementation of quality systems and processes for the new facility, ensuring compliance with ​IATF 16949 and ​customer-specific standards (e.g., VDA 6.3, Formel Q, BMW QM-Requirements)....

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

QA MANAGER - DRUG PRODUCT CLINICAL MANUFACTURING (M/F/D) - QUALITY ASSURANCE / PHARMACEUTICAL / CGMP / SYNTHETIC MOLECULES / GMP AUDITS / SAP / VEEVA / GERMAN / ENGLISH PROJECT: For our client, a large pharmaceutical company based in Basel, we are looking for a QA Manager (m/f/d) Drug Product...

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....

Ensure and enforce compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices....

Monitor and execute the data operations and data quality process. May include coordination of testing, error handling, data conversion and/or validation, and audit/compliance actions (Non-Conformance (NC) and/or Corrective Action Preventive Action (CAPA)). Provide tactical direction to third party...

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

• Lead the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications

Select and qualify packaging suppliers to ensure high-quality materials. Collaborate with suppliers to choose optimal packaging for Fresenius Kabi´s products....

• Create, edit, manage and modify all product and process documentation using PLM and ERP software packages.
• Be a part of the Manufacturing team with extensive interactions with the R&D and Quality departments.