Quality Assurance Specialist
Job Description Summary
Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and compliance with the Novartis Quality Management Systems. Prepares documentation for batch release of commercial pharmaceuticals.
Job Description
Major 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).
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.
Executes batch release in compliance with registration.
Minimum Requirements:
Work Experience:
Functional breadth in QC/QA in pharmaceutical industry/biotech with environmental monitoring.
Collaborating across boundaries.
Experience with 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.
Skills Desired:
Continued learning.
Dealing with ambiguity.
GMP procedures.
QA (Quality Assurance).
Quality Control (QC) testing.
Quality standards.
Self-awareness.
Technological expertise.
Technological intelligence.
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