Quality Assurance Manager
3 settimane fa
**Job Title:** Quality Assurance Manager
Location: Remote, Milano
Type: Full-time
Job Description:
As a Quality Assurance Manager at Novartis, you will be responsible for overseeing all production and testing activities to ensure compliance with cGxP, including data integrity and eCompliance. Your key performance indicators will include on-time and GMP-compliant release of dosage forms, no complaints about inspections by authorities in your area of responsibility, and successful support of continuous improvement projects.
Key Responsibilities:
- Oversight of all production and testing activities
- Ensures 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)
Requirements:
- Functional Breadth: QC/QA in pharmaceutical ind./biotech with environmental monitoring & collaborating across boundaries
- Cleanliness zones
- Skills: Continuous Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence
- Languages: English
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