QA Compliance Expert - General Compliance
$60,212–$105,200 year
On-siteKundl, Tyrol, Austria
Kundl, Tyrol, AustriaOn-siteFull Time$60,212–$105,200 yearEnterprise
Full TimeEnterprise
Job Summary
Manage quality aspects and ensure operational business compliance with cGMP, the Quality Assurance Agreement, regulatory requirements, and the Novartis Quality Manual. Organize audits and inspections by authorities, Novartis, and customers, while drafting inspection summaries, creating action plans, and responding to customer objections. Coordinate regulatory inquiries for submissions and GMP renewals, provide data for monthly reporting and APQRs, and author relevant SOPs. Lead quality projects within your area of responsibility, ensuring all activities follow standard operating procedures.
Required Qualifications
- abgeschlossenes naturwissenschaftliches Studium (Chemie, Mikrobiologie, Biologie, Pharamazie, Biotechnologie) oder äquivalente mehrjährige Berufserfahrung
- Mindestens 2 Jahre Berufserfahrung, wenn möglich im GMP-regulierten Pharma-Umfeld
- 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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