Overview
job description summary
- responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cgmp (current good manufacturing practices), the quality assurance agreement, regulatory requirements and the novartis quality manual and is conducted according to the relevant standard operating procedures
responsibilities
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:
critical negotiations.
functional breadth.
project management.
people leadership.
collaborating across boundaries.
operations management and execution.
skills:
continuous learning.
dealing with ambiguity.
employee performance evaluations.
gmp procedures.
people management.
qa (quality assurance).
quality control (qc) testing.
quality standards.
self awareness.
technological expertise.
technological intelligence.
languages :
english.
skills desired
continued learning, employee performance evaluations, gmp procedures, managing ambiguity, people management, qa (quality assurance), quality control (qc) testing, quality standards, self-awareness, technical knowledge, technological intelligence
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