BA
Basilea Pharmaceutica International Ltd29 Tage
Quality Assurance Manager GCP PV GLP(m/w/x)
Vollzeit
Senior
Keine Angabe
Allschwil
Nejo KI-Zusammenfassung
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
Englisch – verhandlungssicher
Deine Vorteile
Attraktive Vergütung
- •Competitive remuneration
Lockere Unternehmenskultur
- •Engaging working environment
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