*summary*:
we are seeking for someone who can support all gxp activities in the quality department.
administers quality systems/ processes including documentation, metrics and monitoring of actions.
*about the role*:
*main accountabilities*:
- maintains applicable standard operating procedures (sops), gxp compliant documentation and records within the novartis quality management system.
- ensures the integrity of all quality systems records and data, as applicable and teamwork of own team with other functions and departments.
- ensures an adequate level of education, gxp knowledge.
- updates and maintains relevant information in electronic systems (e.g.change control, documentation, training).
- follow up and monitoring of e.g.
capas, actions, metrics, quality plan).
- supports quality audits and health authority inspection.
- reporting of technical complaints / adverse events / special case scenarios related to novartis products within 24 hours of receipt -distribution of marketing samples (where applicable)*:
- customer happiness -punctuality rate jobs done on time, following the specified cycle time -consistent compliance with gmp and health, safety and environment guidelines and standard operating procedures -no complaints with regulatory inspections
*requirements*:
- qc/ qa in pharmaceutical ind./ biotech with environmental monitoring &.
- functional breadth.
- collaborating across boundaries
- 2y at least as control quality analyst.
- english.
division
operations
business unit
pharmaceuticals
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.