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 &.
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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