*summary*:
- manages quality aspects and projects within area of responsibility. -ensures and supports overall gxp conformity and compliance with the novartis quality management systems.
*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.
division
operations
business unit
innovative medicines
location
mexico
site
insurgentes
company / legal entity
mx06 (fcrs = mx006) novartis farmacéutica s.a. de c.v.
functional area
quality
job type
full time
employment type
regular
shift work
no
*accessibility and accommodation*:
novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.