Qc Validation Expert
4 settimane fa
QC Validation ExpertLocation: RietiOBJECTIVES/PURPOSE:Primarily responsible for computer systems and analytical instruments validation documentation.Ensure the planning, development, and implementation of validation documentation.Ensuring adherence to data integrity standards, and procedures for computer-related analytical laboratory instruments.ACCOUNTABILITIES:Primarily responsible for ensuring computer systems and analytical instruments validation documentation, inclusive of validation plans, system design and configuration, periodic reviews, and operational activities in alignment with the Computer System Validation (CSV) and Analytical Instrument Qualification lifecycle process.Ensure the planning, development, and implementation of validation documentation and activities.Ensuring adherence to data integrity standards, and procedures for computer-related analytical laboratory instruments.Provide validation leadership for GXP laboratory analytical instrument/computerized systems and applies risk-based methodology to validation/qualification effort in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.Serves as the liaison between QC department, IT, and Quality functions, providing timely and effective response and follow-through in issue resolution during installation and qualification activities.WHAT YOU BRING TO TAKEDA:Master's degree in Science (Chemistry, Pharmaceutical Chemistry, Biology/Biotechnology, or Engineering).Three years of experience in CSV.Proven knowledge of requirements related to quality control and 21 CFR Part 11, EU Annex 11, and GAMP 5.Ability to effectively communicate and multitask.
Prioritize, plan, and actively participate in multi-tasking validation AIQ activities within agreed timelines.Ability to work a flexible schedule and adapt efficiently to program changes.Problem-solving attitude.Good Microsoft Office applications (Excel, PowerPoint, Word).English knowledge and communication skills (verbal and written, including technical writing).More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering our people to shine:Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.LocationsITA - RietiWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #J-18808-Ljbffr
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Qc Validation Expert
3 giorni fa
Lazio, Italia Takeda A tempo pienoQC Validation Expert Location: RietiOBJECTIVES/PURPOSE:Primarily responsible for computer systems and analytical instruments validation documentation.Ensure the planning, development, and implementation of validation documentation.Ensuring adherence to data integrity standards and procedures for computer-related analytical laboratory...
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Qc Validation Expert
4 settimane fa
Lazio, Italia Takeda A tempo pienoQC Validation Expert Location: RietiOBJECTIVES/PURPOSE: Primarily responsible for computer systems and analytical instruments validation documentation.Ensure the planning, development, and implementation of validation documentation.Ensuring adherence to data integrity standards, and procedures for computer-related analytical laboratory...
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Qc Validation Expert
3 mesi fa
Lazio, Italia Takeda Pharmaceutical A tempo pienoBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
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Qc Validation Analyst
4 settimane fa
Lazio, Italia Amaris Consulting 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...
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Qc Validation Analyst
4 settimane fa
Lazio, Italia Amaris Consulting 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...
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Cleaning Validation Supervisor
3 mesi fa
Lazio, Italia Confidenziale A tempo pienoCategoria: Healthcare / PharmaceuticalLuogo di lavoro: LazioIl Cleaning Validation Supervisor si occuperà di coordinare le risorse interne ed esterne responsabili della cleaning validation, implememtando strategie di cleaning validation per le apparecchiature di produzione. Il/La Cleaning Validation Supervisor sarà responsabile delle seguenti attività: -...
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Process Expert
2 settimane fa
Lazio, Italia Advanced Accelerator Applications (Italy) - S... A tempo pienoLocation: Ivrea, ItalyRole Purpose:Provide front line technical and scientific expert support for all process-specific topics to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g.HSE) and to allow continuously improving in quality, productivity efficiency.About...
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Qc Technician Ii
3 giorni fa
Lazio, Italia Takeda A tempo pienoJob Title: QC Technician II (fixed term) Location: Rieti OBIETTIVI/SCOPO Il job holder esegue test microbiologici su tutti gli intermedi di processo, bulk product e campioni di monitoraggio ambientalePartecipa ad attività di validazioneLavora assicurando l'integrità dei dati e la conformità alle SOPs locali, Specifiche, FDA, GLP e cGMPRESPONSABILITA'...
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Qc Technician Ii
3 giorni fa
Lazio, Italia Takeda A tempo pienoJob Title: QC Technician II (fixed term)Location: RietiOBIETTIVI/SCOPOIl job holder esegue test microbiologici su tutti gli intermedi di processo, bulk product e campioni di monitoraggio ambientalePartecipa ad attività di validazioneLavora assicurando l'integrità dei dati e la conformità alle SOPs locali, Specifiche, FDA, GLP e cGMPRESPONSABILITA'Esegue...
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Expert Validation
4 mesi fa
Lazio, Italia Adecco Italia A tempo pienoStiamo cercando due ingegneri di Validazione per un'importante azienda farmaceutica con sede ad Anagni, in provincia di Frosinone.INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA Citt : Anagni (Frosinone) Istruzione: Laurea Magistrale - Tecnico / Ingegneristico - Ingegneria Chimica (LM-22) Conoscenze linguistiche: Inglese - Livello Ottimo Patenti: B Mezzi di...
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Expert Validation
3 mesi fa
Lazio, Italia Adecco Italia A tempo pienoStiamo cercando due ingegneri di Validazione per un'importante azienda farmaceutica con sede ad Anagni, in provincia di Frosinone.Sei una persona appassionata e competente nel campo dell'ingegneria meccanica o chimica?Hai esperienza nella validazione di processi e prodotti nel settore farmaceutico?Sei pronto/a a mettere le tue competenze al servizio di...
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Qc Technician Ii
3 giorni fa
Lazio, Italia Takeda Pharmaceutical A tempo pienoBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
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Qc Technician Ii
3 giorni fa
Lazio, Italia Takeda Pharmaceutical A tempo pienoBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
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Qa Operational Quality Specialist
1 mese fa
Lazio, Italia Merck Kgaa, Darmstadt, Germany A tempo pienoYou will be in responsible for developing and reviewing equipment/process validation projects with a quality focus and risk-based approach.You will interact on a daily basis and develop strong relationships with Operations and other key internal/external stakeholders.Expert with wide-ranging experience in developing, establishing and maintain quality...
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Pds Analytical Development Lead
1 mese fa
Lazio, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Standard (Mon-Fri) Environmental Conditions Office Supporta l'introduzione del nuovo business fornendo valutazioni tecniche e di capacità su richieste nell'area di sviluppo analitico. Suggerisce in fase di valutazione preliminare dei progetti le strategie analitiche più idonee. Redige o revisiona documentazione di sviluppo (protocolli /...
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Qc Scientist I
4 mesi fa
Lazio, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Other Environmental Conditions Office When you're part of the team at Thermo Fisher Scientific, you'll do important and strategic work: you will help customers in finding cures for cancer and several diseases, also rare pathologies, working on new and innovative molecules for strategic therapies and most as promising and innovative drugs...
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Qc Scientist I
4 settimane fa
Lazio, Italia Thermo Fisher Scientific A tempo pienoWork ScheduleOtherEnvironmental ConditionsOfficeWhen you're part of the team at Thermo Fisher Scientific, you'll do important and strategic work: you will help customers in finding cures for cancer and several diseases, also rare pathologies, working on new and innovative molecules for strategic therapies and most as promising and innovative drugs for...
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Qc Scientist I
3 giorni fa
Lazio, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Other Environmental ConditionsOfficeWhen you're part of the team at Thermo Fisher Scientific, you'll do important and strategic work: you will help customers in finding cures for cancer and several diseases, also rare pathologies, working on new and innovative molecules for strategic therapies and most as promising and innovative drugs for...
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R&D Analytical Scientist
3 settimane fa
Lazio, Italia Suanfarma, Sa A tempo pienoFrom our plant in Rovereto (Italy), we are searching for an Analytical Scientist for our R&D team who will develop new analytical methods and prepare reports, standards, and technical documents for R&D projects. This role includes providing technical service and production support for the QC Lab, including documentation related to the validation...
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Qc Scientist I
1 mese fa
Lazio, Italia Thermo Fisher Scientific A tempo pienoWork ScheduleOtherEnvironmental ConditionsOfficeWhen you're part of the team at Thermo Fisher Scientific, you'll do important and strategic work: you will help customers in finding cures for cancer and several diseases, also rare pathologies, working on new and innovative molecules for strategic therapies and most as promising and innovative drugs for...
