Validation Expert

2 settimane fa


Montà, Italia Novartis Pharma Schweiz A tempo pieno

Join 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 requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.Major 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 newproduct 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.Seniority levelSeniority levelEntry levelEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Novartis Pharma Schweiz by 2xSign in to set job alerts for "Validation Specialist" roles.Integration Verification, Validation and Qualification EngineerWe're unlocking community knowledge in a new way.Experts add insights directly into each article, started with the help of AI.#J-*****-Ljbffr


  • Validation Expert

    1 settimana fa


    Montà, Italia Novartis A tempo pieno

    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...

  • Validation Expert

    7 giorni fa


    Montà, Italia Production Manufacturing A tempo pieno

    SummaryThe 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...

  • Validation Expert

    1 settimana fa


    Montà, Italia Novartis Acc A tempo pieno

    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.ResponsibilitiesSupport site validation planning by writing...

  • Validation Expert

    1 settimana fa


    Montà, Italia Jobs For Humanity A tempo pieno

    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.About the RoleMajor accountabilities :Support site validation...

  • Validation Expert

    2 settimane fa


    Montà, Italia Jobs For Humanity A tempo pieno

    Novartis 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...


  • Montà, Italia Jobs For Humanity A tempo pieno

    A 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,...


  • Montà, Italia Jobs For Humanity A tempo pieno

    A 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...

  • Gmp Validation Specialist

    1 settimana fa


    Montà, Italia Novartis Acc A tempo pieno

    A 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...


  • Montà, Italia Novartis Pharma Schweiz A tempo pieno

    A leading pharmaceutical company in Piemonte, Italy, is seeking a Validation Expert to execute and manage validation activities in compliance with cGMP requirements.The ideal candidate will have a scientific degree and experience in a sterile GMP environment.Strong communication skills in Italian and English are essential for this role, as you will work...


  • Montà, Italia Novartis A tempo pieno

    A 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...