Quality Assurance Operations Specialist
2 giorni fa
At Thermo Fisher Scientific, you'll be part of a global team that makes a meaningful impact on a large scale. Our mission is to enable our customers to create a healthier, cleaner, and safer world by developing innovative solutions to tackle some of the world's most challenging problems, such as protecting the environment, ensuring food safety, and finding cures for cancer.
About UsWe're an innovative facility that supports clients in manufacturing clinical trial batches of sterile injectable products. As part of our Quality operation team, you'll work in a dynamic and exciting environment with a strong GMP background and effective interpersonal skills. You'll be involved in project meetings for new and ongoing projects and will be responsible for related GMP documentation (PSF, APR, Quality Agreements, SOP) and quality operations activities to ensure batch release.
Responsibilities- Review Master Batch Records, perform Batch Record Review, and generate supporting documentation for batch release.
- Manage deviations, investigations, and complaints in collaboration with all relevant functions.
- Support the organization of technical and managerial meetings with clients and participate in customer visits and audits by customers and/or regulatory authorities.
- Contribute to achieving 'zero past due' objectives in Quality (CAPA, Complaints, Deviations) within one's scope of responsibility and RFT (Right First Time) and OTD (On-Time Delivery) objectives for document submission to the client and lot release.
- Provide quality support to customers by responding to inquiries.
- Conduct training for personnel involved in Quality activities for PDS.
To succeed in this role, you'll need:
- A degree in Chemistry, CTF, Biological Sciences, or a similar field.
- Mult-year experience in Quality Assurance Operations teams, with a focus on deviation management and support to GMP manufacturing.
- Excellent knowledge of GMP and national/international regulations.
- The ability to write, handle, and review GMP documentation (Quality Agreement, CAPA) and understanding of main quality indicators such as RFT (Right First Time) and OTD (On-Time Delivery).
- Good problem-solving abilities, excellent communication and team working skills, and the ability to prioritize under time constraints.
- Italian and English language proficiency.
$80,000 - $110,000 per year, depending on location and experience.
-
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob OverviewWe are seeking a highly skilled and experienced Senior Pharmaceutical Quality Assurance Specialist to join our PDS Business unit at Thermo Fisher Scientific Inc. 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.
-
Monza, Lombardia, Italia Mygwork A tempo pienoThermo Fisher Scientific is an inclusive employer and a member of Mygwork – the largest global platform for the LGBTQ+ business community. We're seeking a Quality Vendor Management Specialist to join our team in Monza, Italy.About the RoleThis is a unique opportunity to work in a new mRNA GMP facility and contribute to the general compliance of the site....
-
Quality Assurance Specialist for mRNA GMP Compliance
1 settimana fa
Monza, Lombardia, Italia Mygwork A tempo pienoAbout the RoleWe are seeking a Quality Assurance Specialist to join our team in Monza, Italy. As a Quality Assurance Specialist, you will play a crucial role in ensuring the compliance of our mRNA site with quality regulations.Job DescriptionThis is an exciting opportunity to contribute to the general compliance of our mRNA site and ensure that our company...
-
QC NPI Quality Assurance Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleWe are seeking a highly skilled QC NPI Quality Assurance Specialist to join our team at Thermo Fisher Scientific. In this role, you will be responsible for ensuring the quality and compliance of our products.ResponsibilitiesManage the documentation, reordering, and storage of Reference Standards and reagents in the DPS laboratory.Perform...
-
Chemical Quality Assurance Specialist
12 ore fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific, the world leader in serving science, is committed to empowering our customers to drive scientific progress. Our mission is to make the world a healthier, cleaner, and safer place. We achieve this by delivering innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands.The mRNA...
-
Director of Regulatory Compliance and Quality Assurance
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoLead Regulatory Compliance and Quality AssuranceWe are seeking an experienced Director of Regulatory Compliance and Quality Assurance to join our team in Monza, Italy. As a key member of our quality assurance team, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards across all aspects of our...
-
Sterility Assurance Specialist
1 mese fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoWork Schedule StandardEnvironmental Conditions:Our cleanroom environment requires adherence to strict guidelines, including prohibition on hair products, jewelry, makeup, nail polish, perfume, and exposed piercings.Job Description:We are seeking a highly skilled Sterility Assurance Specialist to join our APS Sterility team at Thermo Fisher Scientific...
-
Quality Assurance Engineer
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific is a global leader in the scientific industry, and as a Quality Assurance Engineer, you will play a crucial role in ensuring that our information systems meet the highest standards of quality.About the RoleYou will be responsible for executing validation projects under the supervision of our Automation Engineering & CSV Manager.You...
-
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoDescrizione del RuoloIl nostro team di Gestione della Qualità è alla ricerca di un Specialista per la Gestione della Qualità Operativa che possa supportare il Quality Assurance Operations Team Leader nel giudizio sulle produzioni e sull'ambiente di lavoro. In questo ruolo, sarà responsabile della verifica della documentazione e delle altre informazioni...
-
Project Quality Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleThermo Fisher Scientific is seeking a skilled Project Quality Specialist to support the Quality team in delivering exceptional results.Job SummaryThe successful candidate will provide process assistance and control, building a robust framework that supports an effective approach to projects and infra-department activities.Main...
-
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoCompany OverviewThermo Fisher Scientific Inc. is a world-class leader in manufacturing and providing innovative solutions to make the world healthier, cleaner, and safer.SalaryWe offer a competitive salary of approximately $80,000 - $110,000 per year based on location and experience.Job DescriptionWe are seeking a skilled Manufacturing Process Expert with...
-
Quality Compliance Senior Manager
1 mese fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoRole OverviewThermo Fisher Scientific Inc. is seeking a highly motivated Quality Compliance Senior Manager to join our team in Italy. The successful candidate will play a key role in ensuring site operations meet cGMP and regulatory compliance while maintaining our commitment to exceptional quality standards.Key Responsibilities• Support and facilitate the...
-
Aseptic Manufacturing Specialist
1 mese fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob DescriptionWe are seeking an experienced Aseptic Manufacturing Specialist to support the implementation of new guidelines and ensure compliance with regulatory requirements.Responsibilities:Evaluate Sterility Assurance topics related to new projects, including departments, manufacturing lines, processes, and products.Assess aseptic practices and...
-
Manufacturing Process Quality and Innovation Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleWe are seeking a highly skilled Manufacturing Process Quality and Innovation Specialist to join our team at Thermo Fisher Scientific. This role offers an exciting opportunity for an ambitious individual with a strong drive for constant growth and improvement.
-
Monza, Lombardia, Italia Relizont A tempo pienoRichiediamo un Specialista in Gestione Qualità e Regolamentazione per il nostro ufficio di RONCELLO. La retribuzione sarà commisurata all'esperienza del candidato, con una stima attorno a 35.000 - 40.000 euro annui.Descrizione del ruoloLavorerai nel settore gomma plastica come Regulatory Affairs & Quality Assurance specialist, assicurando la conformità ai...
-
Biotech Quality Control mRNA Specialist
12 ore fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob Description**Thermo Fisher Scientific Inc. - A Leader in Biotechnology**We are seeking a skilled Biotech Quality Control mRNA Specialist to join our dynamic team at Thermo Fisher Scientific, the world's leading biotechnology company.About the Role:Perform high-quality analysis according to Good Manufacturing Practices (GMP) on incoming, in-process, and...
-
Senior Operations Director
7 giorni fa
Monza, Lombardia, Italia Chart Cooler Svc Co Inc A tempo pienoJob OverviewThe Senior Operations Director will play a critical role in implementing business strategies, improving performance, and ensuring compliance across all levels of the organization. This leader will supervise Engineering, Project Management, and Manufacturing Departments, which operate in the design and manufacture of pressure equipment for various...
-
Quality Assurance Chemical Specialist
12 ore fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Us">Thermo Fisher Scientific Inc., a world-renowned leader in scientific research and innovation, is seeking a talented professional to join its exceptional team.">We are committed to enabling our customers to make the world healthier, cleaner, and safer. Our values - Integrity, Intensity, Innovation, and Involvement - drive us to solve complex...
-
Equipment Calibration Specialist
2 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoCompany Overview">The QC Equipment Calibration team is seeking a dedicated Coordinator to provide additional value in the Quality Control Function. As a QC Equipment Calibration Coordinator, you will join the QC Equipment Calibration team, working to guarantee the correct calibration and maintenance status of the QC laboratories equipment of DPS QC...
-
Financial Operations Specialist
3 settimane fa
Monza, Lombardia, Italia F. Hoffmann-La Roche AG A tempo pienoFinance Enterprise Trainee Role OverviewWe are seeking a highly motivated and detail-oriented Financial Operations Specialist to join our Commercial Finance Value Partner department in Roche Diagnostics Italy.This is an exciting opportunity to work with our team, reporting directly to the Lead of the function. You will be responsible for supporting critical...