Pds QA Process

3 mesi fa


Monza, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

As part of the Thermo Fisher Scientific team, you will discover a meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day, enabling our customers to make the world healthier, cleaner and safer

You will have to opportunity to join the Quality team in our Pharmaceutical Development Service Unit, an innovative facility where we support clients in manufacturing clinical trial batches and small-scale commercial batches of sterile injectable products.

Working in a dynamic and very exciting environment, a strong GMP background as well as effective communication skills will be key. You will take part in the design, validation and regulatory approval of life-saving and innovative drugs, where your contribution will make the difference

**Responsibilities**:

- Work closely with cross-functional teams for the process design stage of new products and take part in the definition of process/cleaning validation strategy
- Review all validation documents to assure the production of high-quality pharmaceutical products that meet strict regulatory requirements
- Participate in the investigation related to validation activities, supporting in the impact assessment evaluation and in the implementation of corrective and preventive actions
- Support the regulatory team during the submission phase of new commercial products
- Review change control related to registration and PPQ batches
- Provide quality support for new product transfer and implementation of new processes. Find opportunities for process improvements and lead initiatives to improve the validation process. Assure that accurate cross contamination control strategies are in place to avoid contamination and mix up event

**Requirements**:
We are looking for an ambitious individual with:

- Experience in development and manufacturing of sterile products and, if possible, with experience in process and cleaning validation topics;
- Strong knowledge of regulatory requirements and industry standards;
- Proficient English with advanced written and oral communication skills;
- Proficiency in Microsoft Office software; knowledge of statistical tool and Trackwise software is a plus;
- Good problem-solving abilities, excellent communication and team working skills; ability to multi-task and prioritize to meet important goals. Critical spirit and Attention to details

**What We Offer**

At Thermo Fisher Scientific Inc., we believe in investing in our people. We offer:

- A collaborative and inclusive work environment.
- The opportunity to work with brand-new technology and contribute to impactful projects.

Join us in Monza and be part of a company that is determined to make a difference. Your work will help ensure we continue to deliver innovative solutions that improve the lives of people around the world.



  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Entrerai a far parte dell'unità Pharmaceutical Development Service (PDS) dello stabilimento di Monza, interamente dedicata alla produzione di prodotti iniettabili finalizzati alla sperimentazione clinica. In qualità di QA Project Secialist ti occuperai delle seguenti attività: **COMPITI SPECIFICI/ATTIVITÀ PRIMARIE**: **Controllo lotti per rilascio** -...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $35 billion...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Description When you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality, and innovation. As part of a successful, growing global organization, you will be encouraged to perform at your best. With revenues of more than $35 billion...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWhen you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality, and innovation.As part of a successful, growing global organization, you will be encouraged to perform at your best.With revenues of more than $35 billion and...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeWhen you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $35 billion and the...

  • Pds Deviations

    7 ore fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **SCOPO DELLA POSIZIONE/RESPONSABILITÀ**: Gestire in conformità a cGMP le attività dei progetti PDS. Contribuisce al raggiungimento degli obiettivi “zero past due” in ambito quality, per la parte di propria competenza, e degli obiettivi RFT ed OTD. **COMPITI SPECIFICI/ATTIVITÀ PRIMARIE**: - Partecipa attivamente a tutti gli incontri stabiliti da...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWhen you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality, and innovation. As part of a successful, growing global organization, you will be encouraged to perform at your best. With revenues of more than $35 billion and...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWhen you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality, and innovation. As part of a successful, growing global organization, you will be encouraged to perform at your best. With revenues of more than $35 billion and...

  • Pds Process

    7 mesi fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific sta cercando un Process & Cleaning Validation Specialist per la sua Business Unit PDS che sta vivendo un momento di grande evoluzione. **SCOPO DELLA **POSIZIONE/RESPONSABILITÀ**: Supportare il PDS Process & Cleaning Validation Team Leader nell’assicurare la convalida dei processi aziendali relativi alla produzione di medicinali...

  • Pds Lead

    7 mesi fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo fisher Scientific, World leader in serving Science sta cercando un Lead Operator, Manufacturing per la sua Business Unit PDS. La risorsa opererà in un reparto dove viene eseguita la Visual Inspection, semi-automatica e manuale, di farmaci sterili in flaconi (forma liquida e liofilizzata) o siringhe pre-riempite. I prodotti da sperlare arrivano da...

  • Pds Process

    6 giorni fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific sta cercando un Process & Cleaning Validation Specialist per la sua Business Unit PDS che sta vivendo un momento di grande evoluzione.**SCOPO DELLA **POSIZIONE/RESPONSABILITÀ**:Supportare il PDS Process & Cleaning Validation Team Leader nell'assicurare la convalida dei processi aziendali relativi alla produzione di medicinali...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the...

  • Pds Ctm Intern

    7 ore fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    You will join a newly-built and state of the art Pharmaceutical Development unit, and as a part of our pilot scale manufacturing department, you will support our Clients in developing new manufacturing processes and technology transfer for small scale/clinical trial sterile production. In this role, you will support client’s projects from a readiness...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, we are on a mission to enable our customers to make the world healthier, cleaner, and safer. With over $35 billion in revenues and the largest investment in research and development in the industry, we are a world-class organization that values...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeAt Thermo Fisher Scientific, we are on a mission to enable our customers to make the world healthier, cleaner, and safer. With over $35 billion in revenues and the largest investment in research and development in the industry, we are a world-class organization that values performance,...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob Description At Thermo Fisher Scientific, we are on a mission to enable our customers to make the world healthier, cleaner, and safer.With over $35 billion in revenues and the largest investment in research and development in the industry, we are a world-class organization that values...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, we are on a mission to enable our customers to make the world healthier, cleaner, and safer. With over $35 billion in revenues and the largest investment in research and development in the industry, we are a world-class organization that values...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the...

  • Pds Process

    7 mesi fa


    Monza, Italia Thermo Fisher Scientific A tempo pieno

    **SCOPO DELLA POSIZIONE/RESPONSABILITÀ**: Supportare il PDS Process & Cleaning Validation Team Leader nell’assicurare la convalida dei processi aziendali relativi alla produzione di medicinali iniettabili sterili e alla pulizia degli equipment di produzione, attraverso la scrittura dei protocolli, l’esecuzione delle attività di convalida e la stesura...


  • Monza, Italia Thermo Fisher Scientific A tempo pieno

    Thermo Fisher Scientific, World Leader in serving Science, sta cercando per la business unit PDS di Monza un Manufacturing Assistant Lead CONTESTO: La risorsa opererà in un reparto che produce farmaci sterili 24/7 in flaconi (forma liquida e liofilizzata) o siringhe preriempite, su due linee di produzione pienamente conformi ai nuovi requisiti dell'Annex...