Lavori attuali relativi a PDS Quality Sr Manager - Monza, Lombardia - Thermo Fisher Scientific
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Quality Assurance Specialist
3 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoDescrizione del LavoroIn qualità di QA Project Specialist, ti occuperai delle seguenti attività:Compiti Specifici/Attività Primarie:Supportare la QP e il Quality Operations Manager nel rilascio dei lotti di prodotto, assicurando la conformità alle specifiche attraverso la verifica documentale dei certificati di analisi, la raccolta e l'analisi dei batch...
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PDS Analytical Development Specialist
3 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleWe are seeking a highly skilled and experienced PDS Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmaceutical Development Services (PDS) team, you will play a critical role in ensuring the quality and compliance of our analytical methods and processes.Key ResponsibilitiesDevelop and...
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Specialista Qualità per Clienti
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoDescrizione del LavoroLa nostra azienda, Thermo Fisher Scientific, è leader nel settore della scienza e della tecnologia. Siamo alla ricerca di un Specialista Qualità per Clienti che possa aiutarci a gestire i nostri progetti clinici e commerciali in conformità con le normative GMP.Compiti e ResponsabilitàGestire i GMP Agreement in relazione ai progetti...
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Specialista Qualità per Clienti
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoDescrizione del LavoroLa nostra azienda, Thermo Fisher Scientific, è leader nel settore della scienza e della tecnologia. Siamo alla ricerca di un Specialista Qualità per Clienti che possa aiutarci a gestire i nostri progetti clinici e commerciali in conformità con le normative GMP.Compiti e ResponsabilitàGestire i GMP Agreement in relazione ai progetti...
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Specialista Qualità per Clienti
5 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoDescrizione del LavoroLa nostra azienda, Thermo Fisher Scientific, è impegnata nella ricerca e nello sviluppo di tecnologie innovative per il settore farmaceutico. Stiamo cercando un Specialista Qualità per Clienti che possa aiutarci a gestire i nostri progetti clinici e commerciali in modo efficace e conforme alle normative GMP.Responsabilità del...
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Quality Assurance Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob SummaryThermo Fisher Scientific Inc. is seeking a highly skilled Quality Specialist to join our PDS Business unit. As a Quality Specialist, you will play a critical role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.Key ResponsibilitiesMonitor sterile production lines to ensure compliance...
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Quality Assurance Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob SummaryThermo Fisher Scientific Inc. is seeking a highly skilled Quality Specialist to join our PDS Business unit. As a Quality Specialist, you will play a critical role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.Key ResponsibilitiesMonitor sterile production lines to ensure compliance...
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Specialista di Qualità per Progetti
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoDescrizione del LavoroIn qualità di Specialista di Qualità per Progetti presso Thermo Fisher Scientific, ti occuperai delle attività relative al controllo di qualità dei prodotti farmaceutici clinici e commerciali. Sarai parte dell'unità Pharmaceutical Development Service (PDS) dello stabilimento di Monza, dove lavorerai in stretta collaborazione con il...
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Specialista di Qualità per Progetti
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoDescrizione del LavoroIn qualità di Specialista di Qualità per Progetti presso Thermo Fisher Scientific, ti occuperai delle attività relative al controllo di qualità dei prodotti farmaceutici clinici e commerciali. Sarai parte dell'unità Pharmaceutical Development Service (PDS) dello stabilimento di Monza, dove lavorerai in stretta collaborazione con il...
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Quality Assurance Specialist
3 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoQuality Specialist IThis is an exciting opportunity to contribute to the success of Thermo Fisher Scientific Inc. as a Quality Specialist in our PDS Business unit.Key Responsibilities:Monitor sterile production lines to ensure compliance with quality standards.Implement control measures to maintain quality throughout production activities.Quality...
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Quality Assurance Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob SummaryThermo Fisher Scientific Inc. is seeking a highly skilled Quality Specialist I to join our PDS Business unit. As a Quality Specialist, you will play a crucial role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.Key ResponsibilitiesMonitor sterile production lines to ensure compliance...
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Quality System Manager
5 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAre you looking for a challenging opportunity to lead and shape a world-class quality system? Thermo Fisher Scientific Inc. is seeking a Quality System Manager to join our exceptional team in Italy. As the Quality System Manager, you will have the opportunity to coordinate and support the Quality System through process design and control strategies. Your...
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Quality System Manager
5 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoQuality System ManagerThermo Fisher Scientific Inc. is seeking a Quality System Manager to join our team in Monza, Italy.Main Responsibilities:Coordinate and support the Quality System through process design and control strategies.Build a robust quality regime and a framework that supports an effective approach to Change Control, Documentation and Training,...
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Quality Assurance Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob DescriptionThermo Fisher Scientific Inc. is seeking a highly skilled Quality Specialist to join our PDS Business unit. As a key member of our team, you will play a vital role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.Key Responsibilities:Monitor sterile production lines to ensure...
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Quality System Manager
2 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoLead and Shape a World-Class Quality SystemThermo Fisher Scientific Inc. is seeking a Quality System Manager to join our exceptional team in Monza, Italy.Main Responsibilities:Develop and implement a robust quality regime and framework to support effective change control, documentation, and training.Sponsor and drive continuous improvement programs related...
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Quality Assurance Specialist
1 settimana fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno{"Job Title": "Quality Specialist I", "Job Description": "Work Schedule Standard (Mon-Fri)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob Description Thermo Fisher Scientific Inc. is seeking a highly skilled Quality Specialist I to join our PDS Business unit. As a Quality Specialist, you will play a...
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Quality Compliance Senior Manager
5 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoQuality Compliance Senior ManagerThermo Fisher Scientific Inc. is seeking a highly motivated Quality Compliance Senior Manager to join our team in Monza, Italy. As a key member of our team, you will play a crucial role in ensuring site operations meet cGMP and regulatory compliance while maintaining our commitment to exceptional quality...
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Analytical Development Specialist
1 settimana fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleWe are seeking a highly skilled Pharmaceutical Quality Control Expert to join our team at Thermo Fisher Scientific. As a key member of our PDS Analytical Development GMP Department, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesDevelop and implement analytical documentation...
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Quality Compliance Senior Manager
1 settimana fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno{"title": "Quality Compliance Senior Manager", "content": "Job SummaryWe are seeking a highly experienced Quality Compliance Senior Manager to join our team at Thermo Fisher Scientific. In this role, you will be responsible for ensuring compliance with cGMP regulations and Corporate Standards, as well as leading the preparation and management of Regulatory...
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Quality Compliance Senior Manager
2 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno{"title": "Quality Compliance Senior Manager", "content": "Job SummaryWe are seeking a highly experienced Quality Compliance Senior Manager to join our team at Thermo Fisher Scientific. In this role, you will be responsible for ensuring compliance with cGMP regulations and Corporate Standards, as well as leading the preparation and management of Regulatory...
PDS Quality Sr Manager
4 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.
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