Cleaning Validation Associate

5 mesi fa

Sesto Fiorentino, Italia Lilly A tempo pieno

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Per il nostro stabilimento di Sesto Fiorentino siamo alla ricerca di un/a **Cleaning Validation Associate** che, riportando direttamente al Sr Manager dell’area, avrà il compito di assicurare lo svolgimento del piano di convalida per i macchinari di stabilimento, laboratori e magazzini.

**OBIETTIVI**:

- Assicurare il rispetto dei tempi di convalida, l’esecuzione in linea con la procedura di test e la conformità ai criteri di accettazione applicabili.
- Coordinare le attività nei reparti e svolge attività di aggiornamento dei piani con le funzioni di fabbrica.
- Sovraintendere alle attività di convalida periodica dello stabilimento e definisce il piano di convalida mensile.
- E ‘responsabile dell’esecuzione dei protocolli e dei relativi ordini di lavoro.
- Collaborare nell’esecuzione delle valutazioni periodiche della performance dei macchinari/ impianti.
- E’ responsabile della corretta documentazione dei protocolli di pertinenza.
- E’ responsabile della rimessa in servizio degli impianti/ macchinari a completamento dell’attività svolta.

**RESPONSABILITA’ PRINCIPALI**:

- Definisce le strategie di convalida periodica.
- Elabora i documenti di convalida e ne assicura l’approvazione.
- Sovraintende alle attività di convalida dello stabilimento e assicura l’aderenza al piano di convalida.
- Garantisce la compliance dei test svolti con i requisiti delle qualifiche e dei GQS di riferimento.
- Aggiorna sull’andamento delle convalide/cleaning validation le funzioni interessate.
- Collabora con le altre funzioni di fabbrica al fine di semplificare l’esecuzione delle attività.
- Assicura la disponibilità dei materiali/ risorse necessari per l’esecuzione delle attività di qualifica.
- E’ responsabile dell’esecuzione dei protocolli e degli ordini di lavoro relativi.
- Collabora con il Parenteral Network per verificare che la convalida sia allo stato dell’arte.
- E’ in grado di rispondere come referente tecnico per le attività di calibrazione/ convalida di fronte ad un ispettore esterno in fase di Audit.
- Esegue il troublehooting in caso di problematiche emerse durante le attività di convalida periodica.

**REQUISITI RICHIESTI**:

- Laurea Magistrale in discipline tecniche/scientifiche
- Ottima conoscenza della lingua inglese
- Conoscenza delle tecniche di convalida periodica e cleaning validation
- Conoscenza dei principi di sterility assurance
- Conoscenza dei processi di produzione parenterale
- Pregressa esperienza di scrittura di documentazione técnica
- Buone capacità di analisi e di sintesi dei dati.
- Capacità di analizzare le informazioni e di definire una pianificazione adeguata, tenendo conto della programmazione aziendale.
- Attenzione e precisione nella documentazione delle attività
- Predisposizione al lavoro di team.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

WeAreLilly

  • Associate - Engineering & Computer System Validation Specialist

    2 settimane fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We are seeking a skilled QA Associate - Engineering & Computer System Validation to join our Manufacturing Team in Sesto Fiorentino. The ideal candidate will be responsible for ensuring that validation/qualification of automation systems is compliant with standards.Main responsibilities:Ensure alignment with GMP standards, granting Q oversight over the...

  • Associate - Engineering & Computer System Validation

    5 mesi fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. Eli Lilly Italia is looking for a QA Associate - Engineering & Computer System Validation to join our Manufacturing Team in Sesto Fiorentino. He/She will be responsible of ensuring that Validation/Qualification of Automation Systems is compliant to the...

  • Quality Assurance Associate

    2 settimane fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We are seeking a skilled Quality Assurance Associate to ensure the Validation/Qualification of Automation Systems is compliant to GMP standards.The successful candidate will be responsible for:Ensuring alignment with GMP standards and granting Q oversight over Computer Systems and EngineeringApproving maintenance programs and Validation deliverablesGiving...

  • Quality Assurance Associate

    1 mese fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We are seeking a highly skilled and detail-oriented Quality Assurance Associate to join our Engineering & Computer System Validation team in Sesto Fiorentino.The ideal candidate will have a strong background in engineering and computer systems, with a focus on validation and quality assurance. They will be responsible for ensuring that our automation systems...

  • Quality Assurance Associate

    4 settimane fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our Engineering & Computer System Validation team in Sesto Fiorentino.The ideal candidate will have a strong background in engineering and computer systems, with a focus on ensuring compliance with GMP standards.Main responsibilities include:Ensuring alignment with GMP...

  • Quality Assurance Associate

    3 settimane fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We're looking for a highly skilled QA Associate to join our Manufacturing Team in Sesto Fiorentino. The ideal candidate will be responsible for ensuring that Validation/Qualification of Automation Systems is compliant to the standards.The successful candidate will support cross-functional teams in investigating and addressing Computer Systems and...

  • Quality Assurance Associate

    3 settimane fa

    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We're looking for a dedicated professional to ensure the quality and compliance of our engineering and computer systems.The ideal candidate will have a strong background in engineering and quality assurance, with excellent knowledge of GMP standards and manufacturing computer systems.Main responsibilities:Ensure alignment with GMP standards and grant quality...

  • Process Automation Associate

    6 mesi fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Process Automation Associate

    6 mesi fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate - Quality Assurance Drug Product External Manufacturing

    1 settimana fa

    Sesto Fiorentino (FI), Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate - Quality Assurance Drug Product External

    1 mese fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance Shop Floor Manager

    5 mesi fa

    Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Simulator Technician I

    5 mesi fa

    Sesto Calende, Italia CAE A tempo pieno

    **Role and Responsibilities** **About CAE**: At CAE, we equip people in critical roles with the expertise and solutions to create a safer world. As a technology company, we digitalize the physical world, deploying software-based simulation training and critical operations support solutions. Above all else, we empower pilots, cabin crew, airlines, defence...