Requirements: English
Company: Angelini Pharma
Region: Ancona , Marche
Requisition ID : 6015Location : Ancona, ITCompany : ANGELINI PHARMA SPAProfessional area : Engineering, Production, QualityJob DescriptionWe have an opportunity for a Chemistry Manufacturing Control Specialist for our Product Quality Compliance team located in Ancona.Job PurposeAccountable for the management of Quality Dossier for medicinal products at the time of submission and during lifecycle, ensuring compliance with Angelini global/local procedures and with national and international law/regulations for Angelini products. Ensure interaction and alignment with the Competent QA, Local/Global RA team, R&D, manufacturing sites to support relevant priorities and objectives.Major ActivitiesDrafting of the Common Technical Document - Module 3 Quality, including management of 3.2.S Drug Substance based on Drug Master File and/or Certificate of Suitability, Module 2.3, 1.4.1, and other applicable documentation necessary for submission.Lifecycle management of Marketing Authorization Applications (MAs): change impact assessment and quality variations.Management of Competent Authority queries (Deficiency letters).Participation in project teams with management of design control during product development.RequirementsDegree in Pharmaceutical Chemistry & Technology or Pharmacy.At least 1 year of experience in Pharma CMC, or alternatively in QA, RA, or R&D.Good understanding of product development and approval processes for new launches and Lifecycle Management.Innovative and critical thinking with a performance-oriented drive.Excellent interpersonal, communication, and presentation skills.Proficient in Microsoft Office (Word, Excel, etc.); familiarity with TrackWise Digital tools is a plus.Fluent in English.#J-18808-Ljbffr