Validation Expert
6 giorni fa
Job Description SummaryThe Validation Expert is responsible for executing and managing process primary packaging and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.Job DescriptionMajor accountabilities :Support site validation planning by writing and maintaining master plans for processes cleaning packaging.Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing.Author and review process packaging or cleaning validation protocols & reports ongoing process and cleaning verification protocols & reports.Support execution of validation activities at the shop floor.Reviews Master Batch Records and associated change controls.Confirm revalidation need based on technical changes.Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.Work collaboratively and cross functionally to help ensure that process risks are analyzed appropriately controlled and appropriately documented.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.Work in close collaboration with development organization (or sending site) 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.Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).Essential requirements :Scientific Degree (CTF / Pharmacy / Biotechnology / Chemical Engineering or related field).Previous experience in a similar role within a sterile GMP environment.Knowledge of Quality and IT tools.Fluent in Italian and English.Skills DesiredAssembly LanguageChange ControlChemical EngineeringChemistryContinual ImprovementProcess Cost ReductionData AnalyticsElectronic ComponentsGeneral HSE KnowledgeIncluding Gdp KnowledgeOf Capa KnowledgeOf GMP Lean Manufacturing Manufacturing Process Manufacturing Production Pharmaceutics Process and Cleaning Validation Process Control Process Engineering Risk Management Root Cause Analysis (RCA) Scheduler Six Sigma Sop (Standard Operating Procedure)Key SkillsPythonSOCDebuggingC / C++FDA RegulationsMinitabTechnical WritingGAMPOS KernelsPerlcGMPManufacturingEmployment Type :Full-TimeExperience :yearsVacancy :1#J-*****-Ljbffr
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Validation Expert
2 settimane fa
Montà, Italia Novartis Italia A tempo pienoThe Validation Expert is responsible for executing and managing process, primary packaging and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.About The RoleSupport site validation planning by writing and...
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Validation Expert
6 giorni fa
Montà, Italia Production Manufacturing A tempo pienoSummaryThe Validation Expert is responsible for executing and managing process, primary packaging and cleaning validation activities and changemanagement activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.About the RoleMajor accountabilities:Support site validation...
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Validation Expert
2 settimane fa
Montà, Italia Novartis Pharma Schweiz A tempo pienoJoin to apply for theValidation Expertrole atNovartis Pharma Schweiz4 days ago Be among the first 25 applicantsJoin to apply for theValidation Expertrole atNovartis Pharma SchweizThe Validation Expert is responsible for executing and managing process, primary packaging and cleaning validation activities and changemanagement activities to meet cGMP...
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Validation Expert
2 settimane fa
Montà, Italia Novartis Italia A tempo pienoSummaryThe Validation Expert is responsible for executing and managing process, primary packaging and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.About The RoleMajor accountabilitiesSupport site validation...
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Validation Expert
6 giorni fa
Montà, Italia Jobs For Humanity A tempo pienoSummaryThe Validation Expert is responsible for executing and managing process primary packaging and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.About the RoleMajor accountabilities :Support site validation...
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Validation Expert
1 settimana fa
Montà, Italia Novartis Acc A tempo pienoSummaryThe Validation Expert is responsible for executing and managing process, primary packaging and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.ResponsibilitiesSupport site validation planning by writing...
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Validation Expert
1 settimana fa
Montà, Italia Jobs For Humanity A tempo pienoNovartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach 296 million people worldwide. We want to create an inclusive workplace where every one of us can be our best and...
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Validation Expert — Gmp Process
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Montà, Italia Jobs For Humanity A tempo pienoA prominent health organization in Saluggia, Italy seeks a Validation Expert to manage packaging and cleaning validation activities in compliance with cGMP standards.The ideal candidate holds a scientific degree and has experience in a sterile GMP environment.Key responsibilities include maintaining master validation plans, reviewing validation protocols,...
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Validation Expert — Gmp Process
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Montà, Italia Jobs For Humanity A tempo pienoA healthcare organization is seeking a Validation Expert in Ivrea, Italy.This full-time role involves managing process validation activities and ensuring compliance with cGMP requirements.The ideal candidate will hold a scientific degree and have prior experience in a sterile GMP environment, alongside fluency in Italian and English.Key responsibilities...
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Gmp Validation Specialist
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Montà, Italia Novartis Acc A tempo pienoA leading pharmaceutical company in Italy is seeking a Validation Expert responsible for executing and managing validation activities in compliance with cGMP requirements.You will support validation planning, author protocols and reports, and ensure all validation activities adhere to regulatory standards.The ideal candidate holds a scientific degree and has...
