OverviewACS DOBFAR S.p.A., multinazionale italiana, leader nella produzione di API e Prodotti Finiti, è alla ricerca di un/ununa candidato/a motivato/a per un percorso di tirocinio universitario o post-laurea nell'ambito della microbiologia farmaceutica e dei processi asettici. La risorsa sarà coinvolta in attività chiave legate al controllo della contaminazione, alla qualità e alla compliance regolatoria, collaborando attivamente con team multidisciplinari in un contesto altamente regolato. Il ruolo offre l'opportunità di acquisire esperienza pratica nella gestione delle deviazioni, nel monitoraggio ambientale e dei processi, nonché nella qualificazione e ottimizzazione dei processi asettici. Il/la tirocinante contribuirà inoltre a progetti di validazione, miglioramento tecnologico e assurance della sterilità, supportando al contempo attività di training e audit. Cerchiamo una persona con solide basi scientifiche, forte attenzione al dettaglio e interesse per il settore farmaceutico, desiderosa di sviluppare competenze tecniche e trasversali in un ambiente dinamico e orientato alla qualità.Main responsibilities
Ensure the management of deviations within the assigned scope, evaluating the criticality of processes and products, supporting batch disposition activities, responding to notifications and tasks, and aligning with Quality Operations on corrective and preventive actions.Collaborate with the coordinator in defining the site Contamination Control Strategy key elements, like qualification and requalification activities of aseptic processes: sterilization, environmental monitoring, disinfection of environments, and study of process conditions including airflow visualization.Collaborate with the coordinator in the evaluation and implementation of new microbiological analytical methods.Assess environmental (viable & non-viable), personnel and utilities monitoring data.Perform production oversight to ensure the correct execution of aseptic techniques and processes.Support the delivery of training to staff on Microbiology, Pharmaceutical Hygiene and aseptic techniques.Participate in project teams related to validation, compliance and technological improvement, with focus on sterility assurance and microbiological laboratory qualification activities.Participate in working groups for the definition of rules and procedures in the context of aseptic production.Assess decontamination, sterilization and depyrogenation data for compliance.Support activities during regulatory authorities and customer audits.
Technical/Regulatory Skills Required
Basic knowledge of cGMP regulationsBasic knowledge of aseptic processes and aseptic techniquesBasic knowledge of microbiologyGood experience in technical writing
Soft Skills Required
Effective communication and collaboration abilities across departments and hierarchical levelsGood problem-solving and decision-making skillsGood teamwork skills
IT Skills Required
Proficiency in managing email using OutlookGood knowledge of Microsoft Office (Word, Excel, PowerPoint, etc.)
Language Skills Required
Italian: Native or professional proficiency, written and spoken (C1)English: Professional proficiency, written and spoken (B2)
Education
Chemistry and Pharmaceutical Technology or equivalent degree
Previous experience in the role or in a similar position within the sector
Not necessary
Certifications and Authorizations
Not Applicable
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