Qo Analyst - Tlahuac, México - Novartis

Novartis
Novartis
Empresa verificada
Tlahuac, México

hace 2 semanas

Rodrigo Fernández

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee


Descripción
395039BR


QO Analyst (Products Release):

Mexico


About the role
Li#CDMX#Hybrid

About the role:
We are looking for an associate that can support all GxP activities in the Quality department. Administers Quality Systems including documentation, metrics and monitoring of actions.


Responsibilities:


  • Perform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
  • Controlled issuance of batch records in preparation for manufacturing.
  • Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
  • Assist functional areas with achieving timely and compliant final product disposition of the product.
  • Ensure Specifications in place and are within GMP compliance.
  • Support metric tracking of documentation and release data to ensure continuous improvement.
  • Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
  • CAPA management as well as improving processes within QA Batch release. The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.

Commitment to Diversity & Inclusion:


  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Role Requirements

  • Bachelor on Chemistry or related. Pharmaceutical and Biological Chemist
  • 35years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent Expertise in GxP operations
  • French Portuguese Knowledge of GMP

Division
Operations


Business Unit

QUALITY

Work Location
Ciudad de México


Company/Legal Entity

NOV CORPORATIVO MEX

Functional Area
Quality


Job Type
Full Time


Employment Type
Temporary


Shift Work
No


Early Talent
Yes

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