Regulatory and Quality Control Support

4 settimane fa

Brindisi, Italia EUROAPI A tempo pieno

Euroapi is looking for an highly motivated person who join out Brindisi site team in the frame of the project of Regulatory Compliance. you will perform in Quality Control Department statistical evaluation of analytical raw data, chemical-physical analysis and analytical method validation according to priorities defined by the Project Manager. You will be responsible of the proper reporting and archiving of the data generated.

Your Responsibilities

You will:

Perform chemical-physical analysis to support activities for regulatory compliance needs on API, Intermediate and Starting Materials, according to priorities defined by Project Manager Prepare solutions and other materials necessary for carrying out laboratory activities. Perform data collection and statistical evaluation of the data collected. Manage meetings and regular touch points with external provider, if involved in the analytical method development and/or analytical method validation. Prepare analytical protocol validation and carry out the validation exercises. Prepare the report of analytical method validation. Collaborate in evaluation for implementation of new analytical techniques and perform the analytical activities. Formalize documentation of analytical tests and results according to cGMP rules. Documentation is generated and completed either by writing (signatures, dates, etc.) or through the use of specific computer programs. Store internal laboratory documentation according to cGMP requirements. Collaborate in carrying out the Quality Control environmental and safety management program in accordance with assigned procedures.

We offert a fixed term 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 R&D biotechnological center. It is approved by the main health authorities and owns environment and workplace safety certifications.

Our Requirements

Master degree in Pharmaceutical Chemistry, Pharmacy, Chemistry.

Ability to work in a team. Good work organization skills.

Good knowledge of computer systems, use of Microsoft Office package.

Good level of English (written and spoken)

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.

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.

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