Euroapi is looking for a RSO Support to join Quality department in our Brindisi site reporting directly to RSO Manager; you will work on submission to Health Authorities and you will give a key contribution to State of Art activities.Your ResponsibilitiesYou will:Support RSO Manager for State of Art activitiesManage change controls related to State of Art ActivitiesInteract with corporate functions managing State of Art projects at corporate levelInteract with external laboratories conducting identification activitiesPrepare CMC (Chemistry/Manufacturing/Control) documents related to active ingredientsCoordinate activities at site level related to State of ArtCollect and evaluate data from Quality Control LaboratoryPerform gap analysis between site quality documentation and regulatory dossiersWrite SOPs with regulatory topicsPrepare administrative documentation for regulatory submission to Health AuthoritiesSupport RSO Manager for regulatory submission to Health AuthoritiesThis is a fixed term contract offer.Our CompanyEUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers' and patients' needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe (Saint-Aubin-lès-Elbeuf and Vertolaye in France, Brindisi in Italy, Frankfurt in Germany, Budapest in Hungary and Haverhill in the UK), EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.EUROAPI is listed on Euronext Paris.The EUROAPI Italy facility is a vast production site with over 240 workers located in the industrial area of Brindisi with a history dating back to 1966. EUROAPI Italy is specialized in the development and manufacturing of Active Pharmaceutical Ingredients (APIs), including antibiotics, corticosteroids, and other intermediates by large scale fermentation under GMP conditions. The Brindisi site produces approximately 200 tons of different molecules per year and hosts a R&D biotechnological center. It is approved by the main health authorities and owns environment and workplace safety certifications.Our RequirementsPreferable a Master degree in regulatory affairsUnderstanding of chemistry/analyticsGood English level: both written and spoken language. DMF are in English language. He/she has to interact with international colleaguesAt least 1 year experience in a GMP QC laboratoryAt least 1 year experience in API regulatory affairs departmentAbility to work in team and to establish open and collaborative human relationshipHigh determination on results achievement and target accomplishmentAnnual BonusTraining & DevelopmentFlexible start time from 8 to 938 hours per week, Monday-Friday 8-16:30Company canteen in the siteCulture & Values at EUROAPIWe bring our culture to life in the way we work every day. Our culture enables career development and talent management, we recognize that how we do things is as important as what we do, and our values set out how we achieve our goals and help us "do it right".Diversity & InclusionEUROAPI is committed to nurturing a culture of diversity and inclusion that contributes to improving innovation, performance, and engagement. We value transparency, mutual respect, and equal treatment of people. For this reason, we are firm in protecting our employees against any forms of discrimination.Environment, Social and GovernanceWe strongly believe that the success of our company lies in its capacity to adapt to tomorrow's challenges. Our responsibility as a company is to provide sustainability and resilience to the pharmaceutical value chain.Apply Today!Find out more about this exciting opportunity, apply today or contact Michaela Perrone.Do you know someone for this role?We are accountable for the success of EUROAPI and that means finding the best people that share our values. Refer a candidate today or talk to your HR Business Partner to find out more.About Us EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers' and patients' needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. Find out more at www.euroapi.com#J-18808-Ljbffr
