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Quality Compliance and Regulatory Affairs

vor 4 Monaten

Friesoythe, Niedersachsen, Deutschland MSD Vollzeit

Job Description

Zur Verstärkung unseres Teams an unserem Standort Friesoythe suchen wir ab sofort in Vollzeit eine/n Quality Compliance and Regulatory Affairs Specialist (m/w/d).

AUFGABEN:

  • Ansprechpartner für standortspezifische, regulatorische Anfragen weltweit (gemäß definierter Produktverantwortlichkeit)
  • lokale, zulassungstechnische Koordination von u.a., Neueinreichungen z.B. Entwicklungsprojekten, Zulassungsänderungen (z.B. Major and Minor)
  • Variations, Zulassungsverlängerungen ('Renewals'), Minor Changes and Stability Reports (MCSR).
  • Anfordern, Erstellen, Zusammenstellen und Pflege der pharmazeutischen Stammdokumentationen
  • Prüfung der Ausgabe von Herstell- und Abfüllvorschriften
  • Erstellung und Prüfung von Spezifikationen
  • Regulatorischer Vertreter im Change Management System
  • Verantwortlich für die Stammdatenpflege in SAP, z.B. Material Listings, Genehmigung von BOMs, Vererbungsregeln etc.
  • Interdisziplinäre Zusammenarbeit mit lokalen und globalen Funktionen im Konzern

QUALIFIKATIONEN:

  • Abgeschlossenes Hochschulstudium im naturwissenschaftlichen Bereich oder vergleichbare Ausbildung
  • Mehrjährige Berufserfahrung in der pharmazeutischen Industrie oder einer anderen stark regulierten Branche in der biologischen oder chemischen Industrie, die nach Qualitätsstandards arbeitet (z.B. nach ISO, USDA usw.), vorzugsweise in qualitätsrelevanten Funktionen
  • Kenntnisse in US-FDA, EU-GMP-Regularien und andere GMP Regularien oder Bereitschaft sich in diese Einzuarbeiten
  • Mehrjährige Kenntnisse in Projektmanagement wünschenswert
  • IT-Kenntnisse betreffend der gängigen MS Office Programme sowie SAP
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

BENEFITS:

  • Gleitzeit (37,5 Stunden / Woche)
  • Attraktives Vergütungspaket: 13 Monatsgehälter, Zielbonus und Zukunftsbetrag
  • Attraktive betriebliche Altersvorsorge inklusive Pflegeversicherung
  • 30 Tage Urlaubsanspruch plus Urlaubsgeld (1.200€ jährlich)
  • Corporate Benefits und betriebliches Gesundheitsmanagement
  • Zuschuss zu Fahrradleasing und Fitness-Mitgliedschaft (Hansefit)
  • Interne Weiterbildungs- und Fördermöglichkeiten inklusive Training-on-the-Job

Das erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur Aufgabe gemacht hat, Kunden und Patienten in jedem Einzelfall zuverlässig und pünktlich mit qualitativ hochwertigen Produkten zu beliefern.

Wir sind stolz darauf, ein Unternehmen zu sein, das auf den Werten seiner vielfältigen, talentierten und engagierten Mitarbeiter aufbaut. Der schnellste Weg innovative Entwicklungen voranzutreiben ist, unterschiedliche Ideen in einer integrativen Umgebung zusammenzubringen. Wir bestärken unsere Kollegen darin, sachlich über ihre Vorstellungen zu diskutieren und Probleme gemeinsam anzupacken. Wir sehen uns als Arbeitgeber der Chancengleichheit und engagieren uns dafür, integrative, vielfältige Arbeitsplätze zu fördern.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/29/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/29/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R295402