Oversight of all production and testing activities, ensures compliance with c Gx P, incl. data integrity and e Compliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support Op Ex 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 &.