Pharmaceutical Process Specialist
3 settimane fa
Job Title: Pharmaceutical Process Specialist
As a key member of the Thermo Fisher Scientific team, you will be responsible for designing, validating, and ensuring the regulatory approval of life-saving and innovative drugs. Your contributions will make a significant difference in the quality of our pharmaceutical products.
Responsibilities:
• Work closely with cross-functional teams for the process design stage of new products.
• Participate in the definition of process/cleaning validation strategy and review validation documents to ensure the production of high-quality pharmaceutical products that meet strict regulatory requirements.
• Support the regulatory team during the submission phase of new commercial products and review change control related to registration and PPQ batches.
• Provide quality support for new product transfer and implementation of new processes, and find opportunities for process improvements and lead initiatives to improve the validation process.
Requirements:
• A degree in Medicinal Chemistry and Pharmaceutical Technologies, Pharmacy, Chemistry, Chemical Engineering, or Biotechnology, or related scientific subject areas.
• Experience in development and manufacturing of sterile products and process and cleaning validation topics.
• Strong knowledge of regulatory requirements and industry standards.
• Proficient English with advanced written and oral communication skills, and proficiency in Microsoft Office software, and knowledge of statistical tools and Trackwise software is a plus.
• Good problem-solving abilities, excellent communication and team working skills, and ability to multi-task and prioritize to meet important goals.
What 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.
-
Pharmaceutical Recruitment Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob SummaryWe are seeking a skilled Pharmaceutical Recruitment Specialist to join our team at Thermo Fisher Scientific. This role will involve recruiting a wide range of positions for our sites in Italy, including manufacturing, operations, commercial, leadership, and corporate roles.Key ResponsibilitiesPartner with Hiring Managers and Field HR partners to...
-
Pharmaceutical Recruitment Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, we're seeking a skilled Pharmaceutical Recruitment Specialist to join our international team. As a key member of our recruitment function, you'll be responsible for sourcing and recruiting top talent for various roles within our Italian sites, including manufacturing, operations, commercial, leadership, and corporate...
-
Pharmaceutical Quality Assurance Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoKey ResponsibilitiesThe Quality Specialist will play a vital role in ensuring compliance with current US GMP, EU GMP regulations, and Thermo Fisher Scientific's quality standards.Key TasksMonitor sterile production lines to ensure compliance with quality standards.Implement control measures to maintain quality throughout production activities.Participate in...
-
Pharmaceutical Development Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Standard (Mon-Fri)As a member of the Thermo Fisher Scientific team, you will contribute to the development of life-saving and innovative drugs. You will work in a dynamic and exciting environment, where a strong GMP background and effective communication skills are key.Responsibilities:Work closely with cross-functional teams for the process...
-
Pharmaceutical Quality Assurance Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, we are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our PDS Business unit. As a key member of our team, you will play a critical role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.Key Responsibilities:Monitor sterile production lines...
-
Senior Pharmaceutical Project Coordinator
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob SummaryThermo Fisher Scientific Inc. is seeking a highly skilled Senior Pharmaceutical Project Coordinator to play a pivotal role in a dynamic, international environment at our Monza site. This role offers an outstanding opportunity to engage with world-class pharmaceutical manufacturing and development, particularly in aseptic injectable drugs and...
-
Pharmaceutical Development Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAs a key member of the Thermo Fisher Scientific team, you will play a vital role in ensuring the quality and integrity of our products.Our company is dedicated to delivering innovative solutions to the pharmaceutical industry, and we are seeking a highly skilled and motivated individual to join our team in the Analytical Development and GMP Department.The...
-
Pharmaceutical Sterility Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Standard (Mon-Fri) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office What Makes This Opportunity Unique At Thermo Fisher Scientific, we provide a highly collaborative and multifaceted environment where you can excel and make a meaningful...
-
Recruiter - Pharmaceutical Industry Professional
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob Title: Recruiter - Pharmaceutical ManufacturingLocation: Monza, ItalyJob DescriptionAs a member of the Thermo Fisher Scientific team, you will play a key role in attracting and retaining top talent for our pharmaceutical manufacturing sites in Italy. Your primary responsibilities will include sourcing candidates, screening resumes, interviewing...
-
Senior Pharmaceutical Project Manager
1 mese fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific is a world leader in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. We are seeking a Senior Pharmaceutical Project Manager to join our team at our Monza site, a state-of-the-art pharmaceutical contract manufacturing and development facility.The successful candidate will work in a...
-
Sterile Production Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob Summary: We are seeking a highly skilled Quality Specialist to join our team at Thermo Fisher Scientific. The successful candidate will play a key role in ensuring compliance with current US GMP, EU GMP regulations, and our company's outstanding quality standards.Key Responsibilities:Assure constant monitoring of sterile production lines to ensure...
-
Pharmaceutical Project Manager for Technology Transfer
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleThe Project Manager will work within the Program & Project Management group, coordinating and responsible for the technology transfer and scale-up of new pharmaceutical products introduced in our commercial manufacturing departments. This role requires strong project management skills, with the ability to empower, coordinate and guide...
-
Specialista Qualità e Processi
4 settimane fa
Monza, Lombardia, Italia Randstad Italia spa A tempo pienoDescrizione del Ruolo:La descrizione del ruolo di Specialista Qualità e Processi presso Randstad Italia spa è la seguente:La risorsa selezionata si occuperà delle seguenti attività:Gestione delle non conformità;Mantenimento delle certificazioni possedute;Definizione degli standard di processo e di prodotto e delle specifiche di controllo...
-
Regulatory Affairs Specialist
1 mese fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific is seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team in Monza, Italy. As a Regulatory Affairs Specialist, you will play a crucial role in supporting the registration process of Patheon Monza site as a manufacturer of sterile medicinal products in the main markets (US, EU, and Rest of the...
-
Quality Assurance Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoThis 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:Ensure the quality and integrity of our sterile injectable pharmaceutical production by monitoring production lines and implementing control measures.Participate in defining and coordinating...
-
PDS Analytical Development Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the Role:We are seeking a highly skilled 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 be responsible for leading analytical development activities, ensuring compliance with GMP regulations, and collaborating with cross-functional teams...
-
Vision System Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoVision System SpecialistAt Thermo Fisher Scientific, we are seeking a skilled Vision System Specialist to join our team. The successful candidate will be responsible for creating and fine-tuning vision recipes on automatic inspection machines and other vision systems. They will ensure the correct functioning of these systems, collaborate with internal teams,...
-
Equipment Qualification Compliance Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, we empower our customers to achieve their goals by providing innovative solutions to complex analytical challenges.Our team of experts delivers an unrivaled combination of technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands.As an Equipment Qualification Compliance Specialist, you...
-
Monza, Lombardia, Italia NonStop Consulting A tempo pienoNonStop Consulting è una società leader nel settore della salute e del benessere che cerca un Specialista di Validazione dei Processi e Pulizia con Focale sul New Product Introduction per conto di un'azienda farmaceutica cliente a Monza.L'azienda, biotecnologica in continua evoluzione, è caratterizzata da un ambiente di lavoro stimolante e dinamico, dove...
-
PDS Analytical Development Specialist
4 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob SummaryAs a PDS Analytical Development Specialist at Thermo Fisher Scientific, you will play a key role in the development and implementation of analytical methods for pharmaceutical products. Your expertise in analytical techniques and instrumentation will be essential in ensuring the quality and compliance of our products.Key ResponsibilitiesDevelop...