BA
Basilea Pharmaceutica International Ltd
29 Tage

Quality Assurance Manager GCP PV GLP(m/w/x)

Vollzeit
Senior
Keine Angabe
Allschwil

In this role, you will oversee quality assurance for GCP, PV, and GLP activities, ensuring compliance and continuous improvement. Your daily responsibilities will include managing audits, training, and non-conformance issues while supporting inspection readiness.

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Anforderungen

  • University degree in pharmacy, chemistry, or equivalent
  • Minimum 10 years of experience in the Pharmaceutical industry
  • Minimum 5 years of experience in QA GCP
  • Excellent knowledge of GCP and PV legislation
  • Experience in auditing GCP, PV, and GLP
  • Experience in GCP/GVP related Health Authority Inspections
  • Familiarity with writing/reviewing regulatory documents
  • Ability to work independently and collaboratively
  • Well-organized and structured
  • Excellent technical and analytical skills
  • Excellent communication and presentation skills
  • Fluency in English written and spoken
  • Any other language would be beneficial
Bachelor-Abschluss

Berufserfahrung

7–10 Jahre

Deine Aufgaben

  • Provide QA oversight for GCP, PV, and GLP activities
  • Act as QA contact for vendors and investigator sites
  • Support continuous improvement of the Quality Management System
  • Establish and update QMS documents
  • Contribute to a risk-based strategy for QA activities
  • Manage non-conformances related to GCP, PV, and GLP deviations
  • Oversee quality issues, investigations, CAPAs, and change control
  • Ensure inspection readiness for Basilea and vendors
  • Review audit findings and generate CAPAs
  • Conduct training for GCP, PV, and GLP activities
  • Prepare for and follow up on audits and inspections
  • Track, record, and report audit results
  • Coordinate and lead internal and external training activities

Sprachen

Englischverhandlungssicher

Deine Vorteile

Attraktive Vergütung

  • Competitive remuneration

Lockere Unternehmenskultur

  • Engaging working environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Basilea Pharmaceutica International Ltd erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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