EXPERT VALIDATION 2 (H/F)

325253BR
Aug 30, 2021
France

Job Description

10 million doses is what the Huningue Biotechnology Center produces each year, which is a center of reference in the production of bio-drugs, clinical and commercial, by culturing mammalian cells.
"Quality and safety depend of course on our high-tech equipment, but they also and above all come from our teams, who bring innovation and improvement for the patient" explains Paula Rosa, Site Manager.
Come join a committed team of 700 people, in a motivating environment

Your responsibilities include, but are not limited to:
• Support site validation planning by writing and maintaining the validation plan for manufacturing and cleaning processes (packaging process is out of scope). Support Validation and Science lead for KPI reporting. Maintain all activities and projects under own responsibility in an inspection ready status
Write and review manufacturing process validation protocols & reports. Support execution of validation activities at the shop floor. Review procedures, Master Batch Records and associated change controls (if applicable). Confirm revalidation need based on technical changes
• Define cleaning validation strategy and evaluate risks related to cleaning (do not author and review neither cleaning validation protocols & reports nor cleaning verification protocols & reports which is PUs’ responsibility)
• Evaluate risks related to Extractables and Leachables and write corresponding protocols and reports (as needed)
Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence. Support Production Units by providing expertise in complex investigations
• Provide scientific and regulatory monitoring related to cleaning/process validation and therefore contribute to continuous cleaning/process and quality improvement. Participate in monitoring and fulfilling commitments to health authorities following dossier submissions and inspections
• Support process validation lifecycle activities but is not responsible for ongoing process verification (OPV is PS responsibility). Support Product Steward in maintaining the process control strategy. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented (as needed)
Work in close collaboration with the Technical Transfer Lead for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready. Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation. Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.

Diversity & Inclusion / EEO

Novartis s'engage à créer un environnement de travail exceptionnel et inclusif, ainsi qu'une équipe diversifiée, représentative des patients et des communautés que nous servons.

Minimum Requirements

Novartis s'engage à créer un environnement de travail exceptionnel et inclusif, ainsi qu'une équipe diversifiée, représentative des patients et des communautés que nous servons.
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Novartis Technical Operations
NTO LARGE MOLECULES
France
Huningue
Technical Operations
Temps plein
Permanent
Non
325253BR

EXPERT VALIDATION 2 (H/F)

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