RSO Support

6 giorni fa

Brindisi, Italia Euroapi A tempo pieno

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

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