394641BR
Apr 22, 2024
Italy
About the Role
Ivrea, Italy (Hybrid) #LI Hybrid
We are seeking a Senior Quality Specialist to support departmental portfolio, projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP.
This role will work directly with the Technical Research and Development (TRD) QA team and reports to the TRD Quality Head.
Key Responsibilities:
• Supporting the TRD QA function within a team of associates, while providing functional expertise to Line Unit and other QA Units in area of responsibility.
• Writing and reviewing GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Supporting project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Providing quality assurance oversight and requirements related to all technical activities (TRD) during the different stages of development, including any technical transfer activities and release requirements.
• Reviewing and ensuring alignment and consistency of Investigational Medical Product Dossier (IMPD/IND) and New Drug Applications (NDA/MAA) prior to any submissions and provide expertise and guidance for responding to health authority queries.
We are seeking a Senior Quality Specialist to support departmental portfolio, projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP.
This role will work directly with the Technical Research and Development (TRD) QA team and reports to the TRD Quality Head.
Key Responsibilities:
• Supporting the TRD QA function within a team of associates, while providing functional expertise to Line Unit and other QA Units in area of responsibility.
• Writing and reviewing GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Supporting project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Providing quality assurance oversight and requirements related to all technical activities (TRD) during the different stages of development, including any technical transfer activities and release requirements.
• Reviewing and ensuring alignment and consistency of Investigational Medical Product Dossier (IMPD/IND) and New Drug Applications (NDA/MAA) prior to any submissions and provide expertise and guidance for responding to health authority queries.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Role Requirements
Essential Requirements:
• Degree in relevant field, or relevant business experience.
• Fluency in English & Italian (both written and oral).
• Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
• Scientific, technical and regulatory knowledge.
• Basic knowledge of drug development.
• Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
• Good organizational skills.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Degree in relevant field, or relevant business experience.
• Fluency in English & Italian (both written and oral).
• Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
• Scientific, technical and regulatory knowledge.
• Basic knowledge of drug development.
• Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
• Good organizational skills.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Development
QA GDD
Italy
Colleretto Giacosa
AAA Italy Srl.
Quality
Full Time
Regular
No
