With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.
Job Purpose
Lo Specialista Assicurazione Qualità garantisce che i processi produttivi, analitici e documentali siano conformi alle normative vigenti (GMP, GDP, normative AIFA) e agli standard di qualità aziendali.
The Quality Assurance Specialist ensures that manufacturing, analytical and documentation processes comply with applicable regulations (GMP, GDP, AIFA) and internal quality standards.
Key Responsibilities
* Garantire la conformità dei processi alle normative GMP e alle procedure interne
* Redigere, revisionare e approvare la documentazione di qualità (SOP, CAPA, Change Control)
* Effettuare indagini (reclami e/o deviazioni) e redigere i relativi report
* Supportare audit interni, audit di clienti e ispezioni da parte delle Autorità Regolatorie
* Collaborare con Produzione, Controllo Qualità e Regulatory Affairs
* Monitorare KPI di qualità e supportare il miglioramento continuo
* Gestire attività di formazione GMP del personale
* Ensure compliance of processes with GMP regulations and internal procedures
* Prepare, review and approve quality documentation (SOPs, CAPAs, Change Controls)
* investigation and related reporting (deviations and/or complaints)
* Support internal audits, customer audits and Regulatory Authority inspections
* Collaborate with Manufacturing, Quality Control and Regulatory Affairs
* Monitor quality KPIs and support continuous improvement activities
* Support GMP training activities
Required Education
Laurea in discipline scientifiche (Chimica, CTF, Farmacia, Biologia o affini)
Degree in a scientific discipline (Chemistry, Pharmaceutical Sciences, Biology or equivalent)
Required Skills And Experience
* Esperienza di almeno 1 anno in Assicurazione Qualità in ambito chimico-farmaceutico
* Conoscenza delle GMP e delle normative di settore
* 1 year of experience in Quality Assurance within the pharmaceutical or chemical industry
* Knowledge of GMP and applicable regulations
Required Languages
Buona conoscenza della lingua inglese
Good knowledge of the English language
Travel required in %
At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.