Euroapi is looking for a RSO Support to join the Quality department in our Brindisi site reporting directly to the RSO Manager.
You will work on submissions to Health Authorities and give a key contribution to State of Art activities.Your ResponsibilitiesYou will:Support RSO Manager for State of Art project activitiesCoordinate activities at site level related to State of ArtManage change controls with regulatory impact related to State of Art projectInteract with corporate functions and external laboratories managing State of Art projectsCollect and evaluate data from Quality Control LaboratoryPerform gap analysis between site quality documentation and regulatory dossiersUnder RSO supervision, prepare CMC (Chemistry/Manufacturing/Control) documents related to active ingredientsContribute to the maintenance and updating of local SOPs related to regulatory topicsUnder RSO supervision, prepare documentation for regulatory submission to Health AuthoritiesSupport RSO Manager for regulatory submission to Health AuthoritiesThis opportunity is for RSO support for a 12-month contract.Our RequirementsPreferably a Master's degree in regulatory affairsUnderstanding of chemistry/analyticsGood English level: both written and spoken language.
DMF is 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 a team and to establish open and collaborative human relationshipsHigh determination on results achievement and target accomplishmentAnnual BonusTraining & DevelopmentFlexible start time from 8 to 938 hours per week, Monday-Friday 8-16:30Company canteen on the siteApply Today!Find out more about this exciting opportunity, apply today!
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