QA Compliance Expert - Analytics
$60,212–$105,200 year
On-siteKundl, Tyrol, Austria
Job Summary
Manage quality aspects within the area of responsibility to ensure operational business compliance with cGMP, the Quality Assurance Agreement, regulatory requirements, and the Novartis Quality Manual. Oversee GxP compliance in IPC and release labs, including approval of qualification plans and reports, while monitoring life-cycle management through periodic reviews, change, and deviation management. Support method validations and transfers, and assist with authority inspections, customer audits, and responses to observations. Collaborate with QC and eCompliance on planning new analytical systems and contribute to unifying GxP standards.
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
- Collaboration
- Communication
- Continuous Improvement
- Data Integrity
- Decision Making
- Good Manufacturing Practices (GMP)
- Leadership
- Managing Ambiguity
- Operational Excellence
- Quality Assurance (QA)
- Quality Compliance
- Quality Control (QC)
- Quality Inspections
- Quality Management Systems (QMS)
- Regulatory Compliance
- Statistical Process Control (SPC)
- Supplier Quality Management
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