QA Compliance Expert - General Compliance
$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. Organize audits and inspections by authorities, Novartis, and customers; draft inspection summaries, create action plans, and coordinate regulatory inquiries for submissions and GMP renewals. Lead quality projects, author SOPs, and provide data for monthly reporting and APQRs. This role requires a natural science degree and at least two years of experience in a GMP-regulated environment, with strong German and English skills. The position offers a salary range of €66,918 to €105,200, with options for part-time, job sharing, and flexible working arrangements.
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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