Validation Expert
1 settimana 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...
4 ore fa
Montà, Italia Healthcare Businesswomen’S Association A tempo pienoJob Description Summary The 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-...
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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
5 ore 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 — Gmp Process
7 giorni fa
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 c GMP 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
6 giorni fa
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
5 ore fa
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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Montà, Italia Novartis Italia A tempo pienoA prominent pharmaceutical company in Piemonte is seeking a Validation Expert to oversee validation activities to ensure compliance with cGMP requirements.The role involves writing validation protocols, collaborating with cross-functional teams, and maintaining master plans for processes.Ideal candidates will have a scientific degree and previous experience...
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Senior Validation Specialist – Sterile Packaging
1 settimana fa
Montà, Italia Novartis A tempo pienoA leading global pharmaceutical company in Italy is seeking a Validation Expert to manage primary packaging and cleaning validation activities to ensure compliance with regulatory requirements.The ideal candidate will have a scientific degree, experience in a sterile GMP environment, and be fluent in Italian and English.Key responsibilities include...
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Montà, Italia Pqe Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal **** , garantendo una presenza internazionale grazie alle 45 filiali e i **** dipendenti in Europa, Asia e nelle Americhe. Lavorare in una realtà di consulenza come PQE Group ti...
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Process Validation Consultant...
8 ore fa
Montà, Italia Mantu Group Sa A tempo pienoWho are we?Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses.With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...
