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Quality Assurance and Compliance Expert
1 mese fa
About the Role
Job Summary:We are seeking a Quality Assurance Specialist to join our team at Novartis Farmacéutica. This is a full-time, temporary (fixed-term) position.
Main Accountabilities:
- Oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
- Support exception investigations.
- Review and approval of production, QC, and AS and T records.
- MBR review.
- Support OpEx improvement projects.
- Qualified Person – Executes batch release in compliance with registration.
- Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
- Distribution of marketing samples (where applicable).
About You:
- Candidates must have experience in QC/QA in pharmaceutical/biotech with environmental monitoring.
- You will be responsible for managing quality aspects and projects within your area of responsibility.
- Ensures overall GxP conformity and compliance with Novartis Quality Management Systems.
Key Performance Indicators:
- On-time and GMP-compliant release of dosage forms.
- No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
- Successfully support continuous improvement projects.
What We Offer:
- An estimated salary range of $80,000 - $110,000 per year.
- A competitive benefits package.
- The opportunity to work with a leading pharmaceutical company.
- A dynamic and collaborative work environment.
How to Apply:
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