Change Control Specialist

Detalles de la oferta

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
- Your main responsibilities:
- 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 partnership of own team with other functions and departments
- Ensures an adequate level of education, GxP knowledge
- Updates & 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 inspections
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
- Distribution of marketing samples (where applicable)

**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.
Degree in engineering or life sciences field
- Shown knowledge of GMP Quality Change Control and Good Documentation Practice.
- 1-2 years of experience in Pharmaceutical Industry.
- Experience in data analysis and reporting.
Local/international Health Regulations management.
Project Management.
- Proven English Knowledge of compliance requirement for all internal and external regulations Knowledge of TQM and related industry GxP standards and processes.
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


Salario Nominal: A convenir

Fuente: Whatjobs_Ppc

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