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Quality Specialist

hace 2 semanas

Ciudad de México Novartis A tiempo completo

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
- Your main responsibilities:
- Ensure that processes are conducted in full compliance with the GxP and the Novartis Quality. Support with regards to GxP relevant documents, processes and systems -Monitoring and reporting of numbers and maintaining of matrices -Training Management, Escalation Management, Risk Management -Provide functional expertise in area of responsibility & represent QA in initiative and act as an interface between departments and within the QA -System administration -Contributes to an improvement of current processes and/or to an implementation of modified processes.
- Develop and improve GxP processes to meet internal and external guidelines -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Transport Deviations
- Act as contact point for Business Partners to lead related investigations to Transport Deviations and ensure compliance with local and global operating procedures. Escalate service related GxP and non-GxP issues to appropriate level to ensure timely investigation.
- Responsible to open, manage and perform investigation report for closure of Major and Transport Deviations for Novartis and Sandoz products, in accordance with company and regulatory requirements. Major Deviations
- Responsible for writing and updating applicable SOP's to align with timeliness aligning with global SOP's.
- Responsible to follow-up the investigation of all Major Deviations to ensure deviation closure General
- Support service harmonization efforts, implementing service quality, turnaround time to customer feedback and improvement projects.
- Responsible to stablish and maintain the KPI´s Responsible for first line support and function as key User for eQMS.

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**
- B.A related to Pharmacy or Chemical-Biological fields.
- 5 years experience in QA/ QC/ Production within Pharmaceutical industry. Handling quality metrics & issues
- French and English proficiency
- Knowledge of GMP Knowledge of CAPA, Good Documentation Practice
- Proven experience using Quality Systems; Continuous Improvement; Good Manufacturing Practices; local/international Sanitary Regulations; IT Systems
- Excellent communicator; Problem Solving; Ability to work under time pressure; Focus on goals; High flexibility; Strives for simplicity and transparency.

Why consider Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
**Division**
- Novartis Technical Operations

**Business Unit**
- NTO QUALITY

**Country**
- Mexico

**Work Location**
- Distrito Federal

**Company/Legal Entity**
- NOV CORPORATIVO MEX

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- Yes