CMC Regulatory Specialist
2 settimane fa
La nostra azienda, Gi Group SpA Filiale di Vimercate, è alla ricerca di un Regulatory CMC Specialist per il suo team di esperti in materia di regolamentazione farmaceutica.
Descrizione del ruolo:
- Redigere documenti CMC per la presentazione di prodotti farmaceutici alle autorità regolatorie europee e extra-europee;
- Collaborare con le divisioni interessate per la realizzazione di progetti e la condivisione degli obiettivi;
- Redigere documentazione CMC per prodotti in industrializzazione e presentarla alle autorità regolatorie;
- Predisporsi e evadere documentazione necessaria per la richiesta di autorizzazione alla produzione, registrazione delle nuove specialità, ottenimento di variazioni alle omologazioni e autorizzazione all'immissione in commercio;
- Preparare risposte alle richieste di pertinenza sezione CMC inoltrate dalle autorità competenti;
- Predisporsi documentazione a sostegno della sperimentazione per la registrazione di nuove specialità;
- Approvare la sezione CMC dei dossier nella funzione di Quality Expert.
Requisiti richiesti:
- Esperienza pluriennale nel ruolo in siti produttivi di farmaci sterili;
- Conoscenza approfondita della regolamentazione farmaceutica europea e extra-europea;
- Abilità di redazione di documenti CMC e di presentazione di prodotti alle autorità regolatorie.
Offerta:
- Contratto a tempo indeterminato;
- CCNL Chimico Farmaceutico;
- Livello e retribuzione verranno discussi in sede di colloquio.
Informazioni sulla nostra azienda:
Gi Group SpA Filiale di Vimercate è una società specializzata nella ricerca e selezione di profili manageriali, executive search, outsourcing, formazione, consulenza HR e amministrazione HR. Siamo presenti in più di 37 Paesi in Europa, Asia e America con un team di oltre 9.000 persone.
I valori che ci contraddistinguono sono l'attenzione, la collaborazione, la passione, la sostenibilità, l'apprendimento continuo e l'innovazione, la responsabilità.
-
CMC Regulatory Specialist
1 settimana fa
Monza, Lombardia, Italia Gi Group SpA Filiale di Vimercate A tempo pienoRegulatory CMC SpecialistLa nostra azienda, Gi Group SpA Filiale di Vimercate, è alla ricerca di un Regulatory CMC Specialist per il suo team di esperti in materia di regolamentazione farmaceutica.Descrizione del ruolo:Redigere documenti CMC per la presentazione di prodotti farmaceutici alle autorità regolatorie europee e extra-europee;Collaborare con le...
-
Regulatory Affairs Specialist
3 settimane fa
Monza, Lombardia, Italia Scientasearch Limited A tempo pienoRegulatory Affairs ManagerAt Scientasearch Limited, we are seeking a highly skilled Regulatory Affairs Manager to oversee the regulatory submissions and processes for our products, from development to post-market approval.Key Responsibilities:Prepare, review, and submit regulatory documents (eCTD Modules 1 and 3) ensuring accuracy and compliance.Respond to...
-
Quality Assurance Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob Title: Quality Specialist IIThermo Fisher Scientific is seeking a highly skilled Quality Specialist II to join our team. As a Quality Specialist II, you will play a critical role in ensuring the quality of our pharmaceutical products.Responsibilities:Ensure that all production activities are conducted in accordance with current US GMP, EU GMP, and...
-
Analytical Development Specialist
22 ore fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJoin Thermo Fisher Scientific as an Analytical Development SpecialistWe are seeking a highly skilled Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmaceutical Department, you will play a critical role in ensuring the quality and compliance of our products.About the RoleAs an Analytical Development...
-
Quality Specialist
2 settimane fa
Monza, Lombardia, Italia Adecco Italia A tempo pienoJob Title: Quality SpecialistAdecco Italia is seeking a Quality Specialist to join our team in Monza. As a Quality Specialist, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Conduct quality audits and inspections to ensure compliance with regulatory requirements and company standards.Develop and implement...
-
Equipment Qualification Compliance Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Thermo Fisher ScientificThermo Fisher Scientific Inc. is a global leader in serving science, with annual revenue exceeding $25 billion. Our mission is to enable our customers to make the world a healthier, cleaner, and safer place.Job DescriptionWe are seeking a highly skilled Equipment Qualification Compliance Specialist to join our team. As a key...
-
Equipment Qualification Compliance Specialist
3 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Thermo Fisher ScientificThermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. Our company has a strong commitment to innovation, purchasing convenience, and pharmaceutical services through our industry-leading brands.Job SummaryWe are seeking a highly...
-
Equipment Qualification Compliance Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Thermo Fisher ScientificThermo Fisher Scientific Inc. is a global leader in serving science, with a strong commitment to innovation and customer satisfaction.Our mission is to enable our customers to make the world a better place through scientific excellence and innovation.Job SummaryWe are seeking a highly skilled Equipment Qualification Compliance...
-
Equipment Qualification Compliance Specialist
5 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Thermo Fisher ScientificThermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. Our company has a strong commitment to innovation, purchasing convenience, and pharmaceutical services through our industry-leading brands.Job DescriptionWe are seeking a highly...
-
Quality Assurance Specialist
7 giorni fa
Monza, Lombardia, Italia Randstad Italia spa A tempo pienoJob Title: Quality Assurance SpecialistRandstad Italia spa is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Conduct quality audits and inspections to ensure compliance with...
-
Equipment Qualification Compliance Specialist
3 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Thermo Fisher ScientificThermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. Our company has a strong commitment to innovation, purchasing convenience, and pharmaceutical services through our industry-leading brands.Job SummaryWe are seeking a highly...
-
Equipment Qualification Compliance Specialist
1 settimana fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Thermo Fisher ScientificThermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. Our company has a strong commitment to innovation, purchasing convenience, and pharmaceutical services through our industry-leading brands.Job DescriptionWe are seeking a highly...
-
PDS Analytical Development Specialist
2 settimane 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 be responsible for leading the development and implementation of analytical methods and procedures to support the production of...
-
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Thermo Fisher ScientificWe are the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.Our TeamWe have a distributed team of over 75,000 colleagues who deliver an unrivaled combination of innovative technologies, purchasing convenience and...
-
Quality Assurance Specialist
3 settimane fa
Monza, Lombardia, Italia Adecco Italia A tempo pienoJob Title: Quality Assurance SpecialistAdecco Italia is seeking a Quality Assurance Specialist for a leading multinational company in the chemical and pharmaceutical industry.Job Summary:We are looking for a highly motivated and detail-oriented Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the...
-
Analytical Development Specialist
2 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJoin Thermo Fisher Scientific as an Analytical Development SpecialistWe are seeking a highly skilled Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmaceutical Development Department, you will play a critical role in ensuring the quality and compliance of our products.Main Responsibilities:Develop...
-
Analytical Development Specialist
7 giorni fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJoin Thermo Fisher Scientific as an Analytical Development SpecialistWe are seeking a highly skilled Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmaceutical Development Department, you will play a critical role in the development and validation of analytical methods for small and large molecule...
-
Analytical Development Specialist
1 settimana fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJoin Thermo Fisher Scientific as an Analytical Development SpecialistWe are seeking a highly skilled Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmaceutical Development Department, you will play a critical role in the development and validation of analytical methods for small and large molecule...
-
Analytical Development Specialist
1 settimana fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJoin Thermo Fisher Scientific as an Analytical Development SpecialistWe are seeking a highly skilled Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Pharmaceutical Development Department, you will play a critical role in the development and validation of analytical methods for small and large molecule...
-
Analytical Development Specialist
3 settimane fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno{"title": "Analytical Development & GMP Department", "description": "Job SummaryWe are seeking a highly skilled Analytical Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our Analytical Development & GMP Department, you will be responsible for testing raw materials, in-process & finished product, formulations according...