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Quality Deviations Specialist

hace 3 meses

Ciudad de México, Ciudad de México Novartis A tiempo completo
391522BR

Quality Deviations Specialist:

Mexico

About the role

Location:
#LI#CDMX#Hybrid

About the role:


We are seeking a Quality Assurance passionate who ensures safe and compliant products for patients (market & clinical) while supporting business priorities.

Build practical quality based relationships with the business partners,

Main responsibilities:

  • Perform and deliver Quality Operations services for Major Deviations and Transport deviations management to support regulatory submission & variation tracking and audit support.
  • Responsible to open, handle and followup the investigation report for closure of Major deviations for Sandoz products manufactured by a third party, in accordance with company and regulatory requirements.
  • Responsible for smooth handling of Major Deviations with appropriate project management skills. Responsible to align with timeliness in accordance with global SOP ́s.
  • Responsible for the extraction and data compilation for preparation of dashboards for all Major deviations open by QSC in the different systems (AQWA, Trackwise or 1QEM) to track and report the results and perform followup actions if required.
  • Bring up service related GxP and nonGxP issues to appropriate level to ensure timely investigation and compliance with local and global operating procedures.
  • Responsible for writing and updating applicable SOP's.
  • Demonstrate customer oriented/service approach in handling and execution of results.
  • Support service harmonization efforts, implementing service quality, turnaround time to customer feedback and improvement projects. Responsible to stablish and maintain the KPI ́s within the quality standards.

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

  • Graduate / Post Graduate in Engineering/Pharmacy/ Science/Statistics or related fields
  • Fluent English and Spanish. Portuguese will be added advantage
  • At least 3 years in QA roles on Pharmaceutical Industry or similar

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.


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
Regular

Shift Work
No

Early Talent
No