Quality Assurance Specialist
Summary
-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. Prepare Documentation for Batch Release of commercial Pharmaceuticals
About the Role
Major accountabilities: Oversight of all production and testing activities, ensures compliance with cGxP, incl. 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. 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. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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