Quality Specialist Document Mgt&art Work - Ciudad de México - Sandoz
Descripción
1996 In this year Sandoz initiated the world's first biosimilar development program.Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide.
This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career within clinical development- Your Key responsibilities:
- Coordinate the issuance and the update of QMS Documents (including Standard Operating Procedures, Work Instructions, FRMs, etc.), in order to ensure compliance with Sandoz standards & Health Authorities requirements.
- Review CAPAs Plans in order to identify required changes (Inclusions, deletions, modifications) in QMS Documents.
- Perform the role of SOP Manager within Electronic Standard Operating Procedure System
- Review Artwork critical parameters (Artwork draft vs. Source document)
- Document Disposition (i.e. Approval/rejection) process.
- Approval/rejection Communication
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
- #Orbit
- 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 the Pharmaceutical Industry or similar
- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? We believe new insights, perspectives and groundbreaking 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 achieve here at Sandoz
Division
- SANDOZ
Business Unit
- Commercial OPS SIR SZ
Country
- Mexico
Work Location
- Distrito Federal
Company/Legal Entity
- SDZ MEX
Functional Area
- Quality
Job Type
- Full Time
Employment Type
- Regular
Shift Work
- No
Early Talent
- Yes
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