Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every patient every day. These core values are: Patients and Partners First, Honesty and Integrity, Quality and Compliance, Collaboration, No-Limits Mindset and Results Oriented.
Your responsibilities:
Act as deputy for the department management representative
Perform support during any required audits, and participate in audit preparation or hosting
Implement any assessed and required QMS procedures from CE for impact to DTI
Write and own department specific documents (as necessary)
Ensure compliance and alignment to applicable regulations within DTI as a whole
Provide support for the alignment of any IT process guidances with the QMS mandatory requirements
Ensure governance of the implementation of any applicable QMS processes within DTI
Support with the oversight of monitoring metrics and reporting to CE for the department
Ensure document control, management and archiving is in place for all DTI documents for GxP systems or processes
Point of contact/SME for any NC or CAPA owned by DTI
Ensure action completion for any tasks out of NC or CAPA required by DTI
Oversee the update and storage of department organizational charts
Ensure the timely deployment of training relevant for departments within DTI
Generate the internal metrics for DTI service, and internal KPIs
Report to Senior QMS Expert the progress of the QMS implementation within DTI
Identify any risks or issues relating to adoption of the processes
Provide guidance/support to other departments implementing a process
Coordinate liaisons between CE and DTI regarding QMS implementation/feedback
Point of contact for DTI employees in understanding if their software is GxP relevant
Ensure IT adopted QMS and IT processes are meeting regulatory requirements and cybersecurity controls
Follows all policies, guidelines, and SOPs as required
Our requirements:
Bachelor's degree in Computer Science, Software Engineering, a Science or a related field or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role
1+ years of professional experience working with or owning computer software validation/system coordination
Strong EN ISO 13485:2016 knowledge
21CFR Part 11 e-signature knowledge
IT service provider/department process awareness
GAMP 5 software validation knowledge
Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements
Relevant experience with Quality system IT Platforms – e.g. Trackwise, Windchill, Agile, IQVIA etc
Experience of working in a company manufacturing under GxP environment
Strong communication and project management skills as well as a strong service and result oriented working style
Additionally, minimum of 3 years of professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred
Fluency in the English language in the business environment (at least B2)
German language knowledge (different than Polish and English) will be an asset.
Knowledge of computer software validation and computer software assurance principals
Willingness to travel within Europe and in the US as needed to support projects.
Our offer:
Private medical care in LuxMed,
PZU life Insurance,
Unlimited international travel Insurance,
Benefits System platform (multisport card, cinema tickets, online shopping etc.)
Language courses reimbursement,
Work abroad possibility (up to 30 days / year)
Recommendation programme
Life milestone bonus
Holiday allowance
Childcare refund
Occasional gifts
Solange die Stellenanzeige angezeigt wird, können Sie sich schnell und einfach bewerben.
Wir teilen unsere Informationen und Erfahrungen untereinander, da wir so aus unseren Fehlern und voneinander lernen können. Wir gehen Herausforderungen gemeinsam an, indem wir uns an Kollegen in der Nähe und in der Ferne wenden. Wir sind offen in unserer Kommunikation.
Wir hinterfragen den Status quo und zeigen Interesse daran, was um uns herum passiert . Wir stellen die nötigen Fragen, um zu verstehen, was getan werden muss. Wir übernehmen Verantwortung für die Ergebnisse.
Wir lassen uns an unseren eigenen Ansprüchen messen, verhalten uns respektvoll und gehen mit gutem Beispiel voran. Unser tägliches Handeln basiert auf Integrität und der Einhaltung unserer Standards.
Wir machen die Dinge heute besser, als sie es gestern waren. Wir bringen unsere Ideen für Verbesserungen und Innovationen ein.
Menschen stärken. Versorgung verbessern. Unser Werte sind unsere Mission.
Wir tun alles, um das Leben der Menschen besser, einfacher und länger zu machen. Unsere Teams arbeiten bereichsübergreifend daran, die komplexe Funktion der Nieren mit Behandlungen zu reproduzieren, die hohen Qualitätsstandards entsprechen, klinische Ergebnisse verbessern, nachhaltig sind und allen Richtlinien entsprechen. Wir fördern Diversität und Inklusion als zentrale Elemente eines positiven, unterstützenden Arbeitsumfelds. Diese Werte helfen uns bei unserer Mission, hochwertige Produkte und Dienstleistungen zu entwickeln, um die Gesundheit und das Wohlbefinden unserer Patienten zu verbessern und Fresenius Medical Care in eine erfolgreiche, nachhaltige Zukunft zu führen.
Diese Stellen könnten Sie auch interessieren: