Qualification and Validation Specialist

3 giorni fa


Lazio, Italia Confidenziale A tempo pieno

Lavoropiu, filale di Pomezia, ricerca per azienda cliente operante nel settore farmaceutico, un qualification and validation specialist / Validazione
- qualificazione - farmaceutico
- Assicurare, attraverso il coordinamento del gruppo assegnato, la gestione delle attività dell’area Ingegneria e Qualifiche relative a Audit, Change Control, strategie di Qualifica, SOP, Risk Assessment, engineering guidelines, rivalutazioni periodiche, archivio.

Attività principali:
Subject Matter Expert e Fronter per tutta l’area di Ingegneria e Qualifiche durante audit regolatori e clienti, organizzazione delle attività di preparazione e risoluzione delle eventuali osservazioni emerse.Partecipare alla definizione delle strategie di qualifica di macchine/impianti.Referente per l’area nelle attività di valutazione e gestione dei Change Control, nella definizione delle attività e della relativa strategia di implementazione e qualifica.

Responsabile della definizione e del monitoraggio delle CAPA scaturite da Audit, Change Control e Deviazioni e delle relative tempistiche.Assicurare l’emissione e il continuo aggiornamento delle Engineering guidelines dei principali impianti ad impatto GMP e delle procedure operative di reparto.Assicurare l’emissione delle rivalutazioni periodiche degli equipment/impianti per certificarne lo stato della qualifica.Assicurare la predisposizione della documentazione di reparto necessaria alle funzioni aziendali.Assicurare la gestione e il mantenimento dell’Archivio documentale degli equipment/impianti di stabilimento.

Requisiti:
Laura in CTF, Biotecnologie o affini con esperienza in ambito Qualità ovviamente ambiente Pharma. Conoscenza inglese parlato e scrittosperienza Una risorsa con 4 / 5 anni di esperienza,

Inquadramento in base all'esperienza, possibile inquadramento C2 / C1

Luogo di lavoro:
Latina

Questo annuncio è



  • Lazio, Italia Buscojobs IT C2 A tempo pieno

    Lavoropiu, filale di Pomezia, ricerca per azienda cliente operante nel settore farmaceutico, un qualification and validation specialist / Validazione- qualificazione - farmaceutico- Assicurare, attraverso il coordinamento del gruppo assegnato, la gestione delle attività dell'area Ingegneria e Qualifiche relative a Audit, Change Control, strategie di...


  • Lazio, Italia Buscojobs A tempo pieno

    Engineering, Maintenance and Technical Services Unit IRBM is a scientific contract research organization (CRO) that stands at the forefront of drug discovery, leveraging a single, unified research facility, located in Pomezia (Rome), Italy, to accelerate team-based breakthroughs and improve efficiencies from initial concept to pre-clinical candidate.With a...


  • Lazio, Italia Irbm A tempo pieno

    Ref.194 BMaintenance and Qualification EngineerEngineering, Maintenance and Technical Services UnitIRBM is a scientific contract research organization (CRO) that stands at the forefront of drug discovery, leveraging a single, unified research facility, located in Pomezia (Rome), Italy, to accelerate team-based breakthroughs and improve efficiencies from...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    Analysis of the technical documentationEnsure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities.- Protocol definitionDraw up...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    Analysis of the technical documentationEnsure, in agreement with the Supervisor, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities.- Protocol definitionDraw up...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office**Analysis of the technical documentation**:Ensure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    **Analysis of the technical documentation**:Ensure, in agreement with the Supervisor, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities.**Protocol definition**:Draw up...


  • Lazio, Italia Txt E-Solutions Spa A tempo pieno

    TXT Group is an international, IT end-to-end provider of consultancy, software solutions and services, supporting the digital transformation of customers' products and core processes. With a proprietary software portfolio and deep expertise in vertical domains, TXT Group operates across different markets, with a growing footprint in Aerospace, Aviation,...


  • Lazio, Italia Lesaffre Iberica Sa A tempo pieno

    Execution of all activities related to qualification and periodic requalification of production machines, utilities (e.g.: HVAC, PRW, Compressed Air, Nitrogen, etc.) of the areas with controlled contamination, laboratory equipment and the validation of related computer systems (CSV) in compliance with Good Manufacturing Standards, national and international...

  • Validation Specialist

    2 settimane fa


    Lazio, Italia Buscojobs A tempo pieno

    Execution of all activities related to qualification and periodic requalification of production machines, utilities (e.g. HVAC, PRW, Compressed Air, Nitrogen, etc.) of the areas with controlled contamination, laboratory equipment and the validation of related computer systems (CSV) in compliance with Good Manufacturing Standards, national and international...

  • Validation Specialist

    2 settimane fa


    Lazio, Italia Buscojobs A tempo pieno

    Execution of all activities related to qualification and periodic requalification of production machines, utilities (e.g. HVAC, PRW, Compressed Air, Nitrogen, etc.) of the areas with controlled contamination, laboratory equipment and the validation of related computer systems (CSV) in compliance with Good Manufacturing Standards, national and international...


  • Lazio, Italia Takeda Pharmaceutical A tempo pieno

    **POSITION**:QC VALIDATION SPECIALIST**:**LOCATION: RIETI**:**ABOUT THE ROLE**:- **Ensure on-time analytical method validation/method transfer/comparability studies activities supporting QC functions.**:- **Support method performance monitoring process.**:**HOW YOU WILL CONTRIBUTE**:- **Writes, reviews, and approves GMP compliant method validation...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office About Thermo Fisher Scientific Inc. Thermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer.As one team of 100,000+ colleagues, we are committed to accelerating research, solving complex...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description About Thermo Fisher Scientific Inc.Thermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we are committed to accelerating research,...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri)Environmental Conditions Office Job Description About Thermo Fisher Scientific Inc.Thermo Fisher Scientific Inc.is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer.As one team of 100,000+ colleagues, we are committed to accelerating research, solving...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeAbout Thermo Fisher Scientific Inc.Thermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we are committed to accelerating research, solving complex...


  • Lazio, Italia Mygwork A tempo pieno

    This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description About Thermo Fisher Scientific Inc. Thermo Fisher Scientific Inc. is a global...


  • Lazio, Italia Thermo Fisher Scientific A tempo pieno

    **How will you make an impact?**Ensure the Quality of the Technical Area Departments, dealing in particular with the management of Customer Audits and Regulatory Inspections, Deviations, CAPAs, Changes, SOPs relating to Process Maintenance and Utilities, Calibrations and Equipment Qualification.**What will you do?**- Support the Quality Department in...

  • Equipment Validation Lead

    3 settimane fa


    Lazio, Italia Thermo Fisher Scientific A tempo pieno

    **Job tasks**:**Analysis of the technical documentation**:Ensure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities.**Protocol definition**:Draw up...


  • Lazio, Italia Takeda Pharmaceutical A tempo pieno

    **POSITION**:CLEANING VALIDATION SPECIALIST**LOCATION**:RIETI**ABOUT THE ROLE**:OBJECTIVES/PURPOSE- Support and execute validation activities related to equipment cleaning procedures.- Develop and execute validation documents as appropriate in compliance with main internal and external guidelines and policies.**HOW YOU WILL CONTRIBUTE**:- Writes I reviews...