Pds Quality Sr Manager
3 mesi fa
Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
Our distributed team delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
PDS business unit at Monza site is looking for a Quality Operations Leader.
Main scope of the PDS Quality Manager / QP: Ensure that Quality Operations meets cGMP and regulatory compliance with respect for the defined methods, current regulations, and corporate quality standards.
Promote accurate and proactive business partnership with site functions and facilitate people and organization development.
Tasks: Product Quality Lead the reporting structure (Quality On The Floor staff and Quality Operations staff ) ensuring the proper review of production manufacturing and documentation, CoAs and possible investigations in full compliance with cGMPs, registration documentation and clients requirements Support the Qualified Person in product disposition and issues assessment Ensure respect for the corporate quality standards through auditing and overseeing the application of the procedures relative to the area managed.
Guarantee the surveillance of on-shift production activities (overlooking and fit&finish in production area), to pro-actively increasing the Quality Culture within the Departments.
Operations Ensure support to site operations to meet cGMP requirements and Corporate Standards Facilitate optimal interactions with clients to ensure the respect of Quality Agreements and to develop business Support operations performance review to identify potential deficiencies and risks, recommend solutions for quality performance issues (e.g.
related to RFT and OTD), promote action plans and improvement initiatives ensuring an accurate follow up Compliance Support the activities of gap analyses versus the GMP regulations updating and new guidelines requests; contribute to the related plan elaboration, including the definition and the monitoring of the accurate corrective actions to ensure GMP site compliance.
Support the site Regulatory Inspections in order to assure that each inspection is properly and effectively managed Budget Support the Supervisor in the preparation of the budget for the function, ensuring supply of the required data and the budget proposal for the area of responsibility, respecting the corporate standards.
Management of organization Manage performance and development of collaborators to ensure achievement of personal and site goals as well as a "great place to work" environment Ensure the direction, coordination and control of the organization managed through the definition of objectives, valuing of the results, analysis of needs for training and development in order to guarantee a high level of performance and motivation.
Personnel management Guarantee that both the initial and the continuous training of the department personnel are performed and is suited to the needs.
The ideal candidate shows leadership skills, ability to manage complex projects, to prioritize.
Expertise in pharmaceutical companies, exposure to clients and regulatory matters is crucial.
Thermo Fisher Scientific is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
Join us
#J-18808-Ljbffr
-
Pds Quality Sr Manager
7 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...
-
Pds Quality Sr Manager
4 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoJob Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.Our Mission is to enable our customers to make the world healthier, cleaner and safer.Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories,...
-
Pds Quality Sr Manager
3 settimane fa
Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...
-
Pds Deviations
7 mesi fa
Monza, 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 Quality Sr Manager
3 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoJob Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their...
-
Pds Quality Sr Manager
4 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoJob Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their...
-
Pds Quality Sr Manager
1 mese fa
Monza, Italia Mygwork A tempo pienoThis 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.Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.Our Mission is to enable our...
-
Pds Deviations
5 giorni fa
Monza, 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
1 giorno fa
Monza, 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
5 giorni 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...
-
Pds Deviations
1 giorno 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...
-
Pds Deviations
3 giorni 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 PDS per i...
-
Intern - Pds Deviations & Client Quality
3 giorni fa
Monza, Italia Thermo Fisher Scientific A tempo pieno**Essential Functions**: - Become familiar with EU and FDA regulations regarding the required statements for the site’s manufactured products. - Provide support to PDS Quality Operation team to perform key product related root cause investigations and identify/provide oversight of the execution of corrective/preventive actions. - Support PDS Quality...
-
Monza, Italia Thermo Fisher Scientific A tempo pieno**Essential Functions**:- Become familiar with EU and FDA regulations regarding the required statements for the site's manufactured products.- Provide support to PDS Quality Operation team to perform key product related root cause investigations and identify/provide oversight of the execution of corrective/preventive actions.- Support PDS Quality Operations...
-
Quality Compliance Sr Manager
5 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Standard (Mon-Fri) Environmental Conditions Office Are you ready to take on a unique opportunity with Thermo Fisher Scientific Inc., the world leader in serving science? We are seeking a highly motivated Quality Compliance Sr Manager to join our team in Monza, Province of Monza and Brianza, Italy. With annual revenue of approximately $40...
-
Quality Compliance Sr Manager
4 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Are you ready to take on a unique opportunity with Thermo Fisher Scientific Inc., the world leader in serving science? We are seeking a highly motivated Quality Compliance Sr Manager to join our team in Monza, Province of Monza and Brianza, Italy. With annual revenue of...
-
Quality Compliance Sr Manager
3 settimane fa
Monza, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeAre you ready to take on a unique opportunity with Thermo Fisher Scientific Inc., the world leader in serving science? We are seeking a highly motivated Quality Compliance Sr Manager to join our team in Monza, Province of Monza and Brianza, Italy. With annual revenue of approximately $40...
-
Pds Purchasing&finance Intern
3 settimane fa
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...
-
Pds Purchasing&Finance Intern
3 settimane fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork 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...
-
Pds Lead
7 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pienoThermo 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...
