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 Responsibilities You will: Support RSO Manager for State of Art project activities Coordinate activities at site level related to State of Art Manage change controls with regulatory impact related to State of Art project Interact with corporate functions and external laboratories managing State of Art projects Collect and evaluate data from Quality Control Laboratory Perform gap analysis between site quality documentation and regulatory dossiers Under RSO supervision, prepare CMC (Chemistry/Manufacturing/Control) documents related to active ingredients Contribute to the maintenance and updating of local SOPs related to regulatory topics Under RSO supervision, prepare documentation for regulatory submission to Health Authorities Support RSO Manager for regulatory submission to Health Authorities This opportunity is for RSO support for a 12-month contract.
Our Requirements Preferably a Master's degree in regulatory affairs
Understanding of chemistry/analytics
Good English level: both written and spoken language. DMF is in English language. He/she has to interact with international colleagues
At least 1 year experience in a GMP QC laboratory
At least 1 year experience in API regulatory affairs department
Ability to work in a team and to establish open and collaborative human relationships
High determination on results achievement and target accomplishment
Annual Bonus Training & Development Flexible start time from 8 to 9 38 hours per week, Monday-Friday 8-16:30 Company canteen on the site Apply Today! Find out more about this exciting opportunity, apply today!
#J-18808-Ljbffr