~Gerer les aspects et les projets de qualite dans le domaine de responsabilite.
~ Assure et soutient la conformite globale GxP et la conformite aux systemes de gestion de la qualite de Novartis.
About the Role
Major Accountabilities
~ Supervision de toutes les activites de production et de test, assure la conformite avec cGxP, y compris l'integrite des donnees et l'eCompliance
~ Soutenir les sondages d'exception
~ Examen et approbation des dossiers de production, de controle de la qualite et des SA et T
~ Examen MBR
~ Soutenir les projets d'amelioration OpEx
Personne qualifiee - executer la liberation du lot en fonction de l'archivage.
~ Declaration des plaintes techniques / evenements indesirables / scenarios de cas particuliers lies aux produits Novartis dans les 24 heures suivant leur reception
~ Distribution d'echantillons de commercialisation (le cas echeant)
Key Performance Indicators
~Gerer les aspects et les projets de qualite dans le domaine de responsabilite.
~ Assure et soutient la conformite globale GxP et la conformite aux systemes de gestion de la qualite de Novartis.
Work Experience
~QC/QA dans l'industrie pharmaceutique / biotech avec controle environnemental et zones de proprete
~Etendue fonctionnelle
~Collaborer par dela les frontieres
Skills
~Veille technologique
~QA (Assurance Qualite)
~Procedures BPF
~Normes de qualite
~Tests de controle de la qualite (Qc)
~Faire face a l'ambiguite
~Conscience de soi
~Apprentissage continu
~Expertise technologique
Language
Anglais
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Operations
Business Unit
Other
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Quality
Job Type
Full time
Employment Type
CDI
Shift Work
No
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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