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.