QA Compliance Expert - Analytics
$60,212–$105,200 year
On-siteKundl, Tyrol, Austria
Job Summary
Manage quality aspects and ensure operational business compliance with cGMP, the Quality Assurance Agreement, regulatory requirements, and the Novartis Quality Manual. Oversee GxP compliance in in-process control, release laboratories, analytical production labs, associated devices, and IT systems, including approval of qualification plans and reports. Monitor life-cycle management through periodic reviews, change and deviation management, and risk assessments while supporting method validations and transfers. Collaborate with QC and eCompliance on planning new systems for the "Digital QC" initiative and assist with authority inspections, customer audits, and addressing non-conformances.
Required Qualifications
- abgeschlossenes naturwissenschaftliches / technisches Studium (Chemie, Mikrobiologie, Pharmazie, Biotechnologie) oder äquivalente mehrjährige Berufserfahrung
- Mindestens 2 Jahre Berufserfahrung, wenn möglich im GMP-regulierten Umfeld der Pharma
- Erste Erfahrung mit Compliance innerhalb der QA, QC oder Produktion
- Sehr gute Deutsch- und Englischkenntnisse
Desired Qualifications
- Mindestens 2 Jahre Berufserfahrung, wenn möglich im GMP-regulierten Umfeld der Pharma
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