Quality Assurance Specialist

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 PurposeLo 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 ResponsibilitiesGarantire la conformità dei processi alle normative GMP e alle procedure interneRedigere, revisionare e approvare la documentazione di qualità (SOP, CAPA, Change Control)Effettuare indagini (reclami e/o deviazioni) e redigere i relativi reportSupportare audit interni, audit di clienti e ispezioni da parte delle Autorità RegolatorieCollaborare con Produzione, Controllo Qualità e Regulatory AffairsMonitorare KPI di qualità e supportare il miglioramento continuoGestire attività di formazione GMP del personaleEnsure compliance of processes with GMP regulations and internal proceduresPrepare, 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 inspectionsCollaborate with Manufacturing, Quality Control and Regulatory AffairsMonitor quality KPIs and support continuous improvement activitiesSupport GMP training activitiesRequired EducationLaurea in discipline scientifiche (Chimica, CTF, Farmacia, Biologia o affini) Degree in a scientific discipline (Chemistry, Pharmaceutical Sciences, Biology or equivalent)Required Skills And ExperienceEsperienza di almeno 1 anno in Assicurazione Qualità in ambito chimico-farmaceuticoConoscenza delle GMP e delle normative di settore1 year of experience in Quality Assurance within the pharmaceutical or chemical industryKnowledge of GMP and applicable regulationsRequired LanguagesBuona conoscenza della lingua inglese Good knowledge of the English languageTravel 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.#J-18808-Ljbffr