RSO Support Euroapi is looking for a RSO Support to join the 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 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 and 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 a RSO support for a 12 months contract.
Our Company 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 (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 RD biotechnological center.
It is approved by the main health authorities and owns environment and workplace safety certifications.
Our Requirements Degree in biochemistry/chemistry/pharmaceutical chemistry/pharmacy/chemical engineering Preferable a Master degree in regulatory affairs Understanding of chemistry/analytics Good English level: both written and spoken language.
DMF are 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 Your Benefits Competitive Salary Annual Bonus Training Development Flexible start time from 8 to 9 38 hours per week, Monday-Friday 8-16:30 Company canteen in the site Culture Values at EUROAPI We 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 Inclusion EUROAPI 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 Governance We 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.
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