QA Associate - Madrid, España - Novartis
Descripción
2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions.
These will be careers with genuine impact This is one such roleAre you ready to make a difference?
Your Key Responsibilities
Your responsibilities include, but not limited to:
- Release for distribution activities including among others: batch documentation from the plant and other documents associated (deviations, notifications,.), regulatory control of critical parameters (regulatory check). Monthly trend of commercial release data in order to detect recurrences and analyze trends.
- Report and monitoring of monthly indicators
- Collaborate with the QPs at Sandoz Manufacturing Sites (STO) on specific issues (i
e:
deviation with impact on the product)
- Management and prioritization of emergencies and releases.
- Management of repackaging activities commercial batches in accordance with GMPs.
- Stock Out and Shortage management and reporting.
- Supporting Technical Responsible on National Competent Authority management for commercial products (including Medical Devices and food supplements)
- Evaluation of the transport of commercial medication and evaluation in case of temperature excursions.
- Ensure the implementation of SLC jointly with Supply, DRA and other related departments.
- Document management related to release and product.
- Drive standardization and efficiency gains through innovation and operational excellence projects
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
What you'll bring to the role:
- Bachelor of Health Sciences
- Minimum experience of 3 years in Quality Assurance and/or Quality Control. High knowledge of GMPs and drug manufacturing processes.
- Build a reliable and trustable network.
- Fluency in English as a business language (oral and written)
Why Sandoz?
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
- Novartis Technical Operations
Business Unit
- QUALITY
Country
- Spain
Work Location
- Madrid
Company/Legal Entity
- Sandoz Farmacéutica, S.A.
Functional Area
- Quality
Job Type
- Full Time
Employment Type
- Regular
Shift Work
- No
Early Talent
- Yes
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