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Open nowPosted 2 days ago

Engineering Quality & Compliance Specialist

job-room.ch119,207 open roles

Where
St. Gallen, SG, Switzerland
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Your applicationOpen nowEngineering Quality & Compliance Specialistjob-room.ch · St. Gallen, SG, Switzerland

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The clock on this job

Early applications get read.

10.5% of postings close within 7 days. Measured by our own scanner across the market. job-room.ch postings stay open a median of 5 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.3%3 days
  3. 10.5%7 days
  4. 15.9%14 days
  5. 34.1%30 days
This job: posted 2 days ago

job-room.ch median: 5 days open

The posting

Engineering Quality & Compliance Specialist

Über Vifor Pharma:

Vifor Pharma, ein Unternehmen der CSL-Gruppe, ist ein weltweit tätiges Pharmaunternehmen mit Fokus auf innovative Therapien in den Bereichen Eisenmangel, Nephrologie und seltene Erkrankungen. In einem stark regulierten GMP-Umfeld setzt Vifor Pharma höchste Standards in Qualität, Compliance, Patientensicherheit und kontinuierlicher Verbesserung. Das Team Engineering Quality & Compliance trägt maßgeblich dazu bei, die Inspektionsbereitschaft sicherzustellen, Prozesse kontinuierlich zu optimieren und die zuverlässige Versorgung von Patienten weltweit zu unterstützen.

Ihre Aufgabe:

Als Engineering Quality & Compliance Specialist sind Sie verantwortlich für die Koordination und Umsetzung von Qualitäts- und Compliance-Aktivitäten innerhalb des Engineering-Bereichs. Sie treiben Change-Control-Prozesse, Abweichungsmanagement, CAPAs und Risikobewertungen voran und stellen gemeinsam mit verschiedenen Fachbereichen die GMP-Compliance sowie die dauerhafte Inspektionsbereitschaft sicher.

Ihre Verantwortlichkeiten

  • Steuerung und Koordination von Change-Control-Prozessen im Engineering-Umfeld
  • Erstellung, Bearbeitung und Nachverfolgung von Änderungsanträgen (Change Controls)
  • Sicherstellung der fristgerechten Bearbeitung und des Abschlusses von Abweichungen, CAPAs, Complaints und zugehörigen Maßnahmen
  • Durchführung und Moderation von Risikobewertungen und Root Cause Analysen
  • Umsetzung und Nachverfolgung von Verbesserungsmaßnahmen
  • Erstellung und Pflege von Einträgen in Qualitätssystemen
  • Analyse und Reporting relevanter Qualitäts- und Compliance-Kennzahlen
  • Enge Zusammenarbeit mit Qualitätssicherung, Qualitätskontrolle, EHS, Regulatory Affairs, Metrologie und F&E
  • Unterstützung bei Qualifizierungsprojekten und technischen Änderungen
  • Vorbereitung, Begleitung und Vertretung des Fachbereichs bei GMP-Inspektionen und Audits
  • Sicherstellung einer kontinuierlichen Inspektionsbereitschaft und Einhaltung regulatorischer Anforderungen

Erfolgsfaktoren

  • Keine überfälligen Actions, Abweichungen, CAPAs, Complaints oder Change Controls
  • Zeitgerechte Durchführung von Untersuchungen und Risikobewertungen
  • Nachhaltige Implementierung wirksamer Corrective and Preventive Actions (CAPAs)
  • Hohe GMP-Compliance und permanente Inspektionsbereitschaft
  • Erfolgreiche Umsetzung von Qualitäts- und Prozessverbesserungsinitiativen

Ihr Profil:

Ausbildung & Berufserfahrung

  • Bachelorabschluss in Chemie, Chemieingenieurwesen, Verfahrenstechnik oder einer vergleichbaren Fachrichtung
  • Mindestens 4 Jahre Berufserfahrung in einem regulierten Produktionsumfeld
  • Erfahrung im Change-Management, Abweichungsmanagement, CAPA-Management und GMP-Compliance

Fachliche Kompetenzen

  • Fundierte Kenntnisse der GMP-Anforderungen und Qualitätsmanagementsysteme
  • Erfahrung mit Risikobewertungen, Root Cause Analysen und kontinuierlicher Verbesserung
  • Kenntnisse technischer Medien wie Wasser, Reinstwasser, Dampf, Reindampf und Druckluft
  • Sicherer Umgang mit MS Office und QMS- Tools idealerweise Veeva
  • Verhandlungssichere Deutsch- und Englischkenntnisse in Wort und Schrift

Wünschenswerte Zusatzqualifikationen

  • Weiterbildung im Bereich Operational Excellence, Lean Management oder Six Sigma (Green Belt, Black Belt o. ä.)
  • Erfahrung mit GMP-Audits und Behördeninspektionen

Persönliche Kompetenzen

  • Analytisches und strukturiertes Denkvermögen
  • Ausgeprägte Problemlösungskompetenz
  • Hohe Eigeninitiative und Verantwortungsbewusstsein
  • Starke Kommunikations- und Koordinationsfähigkeiten
  • Teamorientierte Arbeitsweise und bereichsübergreifende Zusammenarbeit
  • Flexibilität und hohe Leistungsbereitschaft
  • Kontinuierliche Verbesserungs- und Qualitätsorientierung

 

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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