Commercial Quality Manager
il y a 1 semaine
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, it's 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:
- Ensure that the requirement of Good Distribution Practices are implemented and maintained within the quality management system.
- Ensure that the applicable Medical Device legislative requirements are implemented and maintained within the quality management system and that Medical Devices are distributed in compliance with FAHMP "Guidance for Distributors of Medical Devices".
- Act as the main contact for competent authorities for Medical Devices.
- Act as the key point of contact for Warehouse and Distribution.
- Support in performing QP batch (import) certification and release for market and distribution in accordance with marketing authorization and GMP requirements;
- Support in preparing for local repackaging activities (components check, release for artwork, etc.).
- Artwork quality review and approval for commercial products.
- Support in document, deviation, change control, complaint, CAPA and incident management within area of expertise.
Imagine what you could experience at Sandoz.
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 will bring to the role:
- University degree in life sciences (e.g. chemistry, pharmacy or other life sciences)
- advanced degree desirable.
- Registration on the list of Qualified Persons as required per RD 14/12/200
- Strong knowledge of GMP/GDP legislative requirements and work experience in a quality organization.
- Fluency in Dutch or French and English is essential.
- Excellent communication and diplomacy skills;
- Excellent administrative management skills;
- Good interpersonal savvy;
- Handson experience with MS excel and other electronic platforms such as SAP, Trackwise.
ORBIT
Possible job locations:
Belgium.
We offer
permanent employment with probation period with flexible working, learning and development opportunities.
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 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 tryingImagine what you could achieve here at Sandoz
Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation
Division
SANDOZ
Business Unit
COMMERCIAL OPS EUROPE SZ
Country
Belgium
Work Location
Vilvoorde
Company/Legal Entity
SDZ BEL
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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