![ThermoFisher Scientific](https://media.trabajo.org/img/noimg.jpg)
PDS Technical Writer&GMP Compliance Specialist
4 settimane fa
Job Description
Job 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 $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
In Monza we offer compliance with controlled drug regulations in Europe and the U.S. as well as disposable manufacturing technologies and fully integrated secondary packaging services, and has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey. The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe and Asia Pacific
You will join the PDS Analytical Development&GMP Department in a new built of Pharmaceutical Department (PDS). Reporting to the PDS AD&GMP Supervisor you are responsible for the assigned projects, responsible for all the documentation related (OOS/OOT/Change control, SOPs and CoA) in such a way as to ensure the successful continuation of the projects within the PDS.
What you will do
- Responsible for the analytical documentation of APIs, Excipients and DP (release and stability tests).
- Collaborate with Clients, QCPDS ,Regulatory Department, QC Compliance, QA and QOin order toissue the correct documents for PDS projects, respecting the ICH and Pharmacopoeia.
- Providecompliance consulting and strategic advice to internal and external clients todeterminethe mostappropriate approachin order tohave compliant documentation for their products.
- Provideproject specific strategy, technicalexpertise in QC Documentation matter and coordination oversight for key client's projects.
- Serve as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projects.
- Responsible for the evaluation of OOS, OOT and laboratory investigation in terms of recurrences, root cause, trend anddefineCAPAs.
- Perform laboratory investigations, laboratory OOS and OOT and any deviations and CAPA related to them Collaborating with Supervisor and Team Leader to manage these.
How will you get there
- Bachelor's degree in chemical engineering, chemistry, or equivalent work experience with pharmaceutical companies.
- GMP standards applied to Quality Control laboratories, withparticular referenceto stabilitystudies, laboratory data management and SOP writing.
- English and Italian
- Flexibilityandadaptability.
- Goodorganizationand planning skills
- Excellent listening, oral, and written communication skills
- Ability to work in ateam
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
-
Pds Deviations
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoIn relazione alle esigenze ed ai progetti in corso di PDS, e alle indicazioni del PDS Deviations & Client Quality Team Leader:- Partecipa attivamente a tutti gli incontri stabiliti da PDS per i progetti nuovi ed in corso di avanzamento;- Revisiona i Quality Agreement Patheon PDS- Cliente;- Redige la documentazione GMP critica (es. PSF, risk assessment di...
-
Pds Deviations
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThe Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that...
-
Pds Analytical Development
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThe Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that...
-
Pds Quality On The Floor Specialist
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno**Job Description**:Thermo Fisher Scientific sta reperendo per la sua sede di Monza un Quality on the Floor Specialist da inserire nella Busines Unit PDSSCOPO DELLA POSIZIONE/RESPONSABILITÀ:Alle dipendenze del PDS Quality on the Floor Team Leader assicura, attraverso l'esecuzione delle attività di verifica e controllo condotte in campo durante le...
-
Pds Quality On The Floor Specialist
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific sta reperendo per la sua sede di Monza un Quality on the Floor Specialist da inserire nella Busines Unit PDSSCOPO DELLA POSIZIONE/RESPONSABILITÀ:Alle dipendenze del PDS Quality on the Floor Team Leader assicura, attraverso l'esecuzione delle attività di verifica e controllo condotte in campo durante le lavorazioni e attraverso la...
-
Pds Quality On The Floor Specialist
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific, Leader mondiale nel servire la Scienza, cerca per il suo stabilimento di Monza, e per la sua Business Unit PDS un Quality on the Floor Specialist**COMPITI SPECIFICI/ATTIVITÀ PRIMARIE**:**Batch Record Review**- Effettua la revisione dei lotti GMP rilevanti (siano essi ad uso umano/veterinario oppure destinati a generare informazioni...
-
Pds Analytical Development and Gmp Intern
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoWhen 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...
-
Lead QA Technician
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific, world leader in serving science, sta cercando per la business unit del sito di Monza un PDS Deviations&Client Quality specialist.La persona identificata, in relazione alle esigenze ed ai progetti in corso di PDS, e alle indicazioni del PDS Deviations & Client Quality Team Leader:- Partecipa attivamente a tutti gli incontri stabiliti...
-
Pds Process
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThermo 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
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob DescriptionThermo 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...
-
PDS Lead
2 mesi fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob DescriptionThermo 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...
-
PDS Process
4 settimane fa
Monza, Lombardia, Italia ThermoFisher Scientific A tempo pienoJob DescriptionThermo Fisher Scientific sta cercando un Process & Cleaning Validation Specialist per la sua Business Unit PDS che sta vivendo un momento di grande evoluzione.SCOPO DELLAPOSIZIONE/RESPONSABILITÀ: Supportare il PDS Process & Cleaning Validation Team Leader nell'assicurare la convalida dei processi aziendali relativi alla produzione di...
-
Intern, PDS
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionJob Description:As a part of our Project Management team, you will support PDS projects in respect to PDS Project Management Supervisor. You will be responsible to support the project management group in respecting the customer timelines. Responsibilities Provide support to senior project...
-
Intern, Pds
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAs a part of our Project Management team, you will support PDS projects in respect to PDS Project Management Supervisor.You will be responsible to support the project management group in respecting the customer timelines.Responsibilities Provide support to senior project managers by drafting minutes, sending agendas and drafting change controls. Facilitate...
-
Intern, PDS
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionJob Description:As a part of our Project Management team, you will support PDS projects in respect to PDS Project Management Supervisor. You will be responsible to support the project management group in respecting the customer timelines. Responsibilities Provide support to senior project...
-
PDS QC Analysis Reviewer
3 settimane fa
Monza, Lombardia, Italia ThermoFisher Scientific A tempo pienoJob DescriptionJob 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 the largest investment in R&D in the industry,...
-
PDS QC Analysis Reviewer
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob DescriptionJob 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 the largest investment in R&D in the industry,...
-
PDS QC Analysis Reviewer
4 settimane fa
Monza, Lombardia, Italia ThermoFisher Scientific A tempo pienoJob DescriptionJob 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 the largest investment in R&D in the industry,...
-
PDS QC Analysis Reviewer
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob DescriptionJob 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 the largest investment in R&D in the industry,...
-
Analytical Development
3 settimane fa
Monza, Lombardia, Italia ThermoFisher Scientific A tempo pienoJob 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 the largest investment in R&D in the industry, we give our...