Microbiology and Sterility QA employee internship

ACS DOBFAR S.p.A., multinazionale italiana, leader nella produzione di API e Prodotti Finiti, è alla ricerca di un un/una 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:

1. 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.
2. 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.
3. Collaborate with the coordinator in the evaluation and implementation of new microbiological analytical methods.
4. Assess environmental (viable & non-viable), personnel and utilities monitoring data.
5. Perform production oversight to ensure the correct execution of aseptic techniques and processes.
6. Support the delivery of training to staff on Microbiology, Pharmaceutical Hygiene and aseptic techniques.
7. Participate in project teams related to validation, compliance and technological improvement, with focus on sterility assurance and microbiological laboratory qualification activities.
8. Participate in working groups for the definition of rules and procedures in the context of aseptic production.
9. Assess decontamination, sterilization and depyrogenation data for compliance.
10. Support activities during regulatory authorities and customer audits.

Technical/Regulatory Skills Required:

1. Basic knowledge of cGMP regulations
2. Basic knowledge of aseptic processes and aseptic techniques
3. Basic knowledge of microbiology
4. Good experience in technical writing

Soft Skills Required:

1. Effective communication and collaboration abilities across departments and hierarchical levels
2. Good problem-solving and decision-making skills
3. Good teamwork skills

IT Skills Required:

1. Proficiency in managing email using Outlook
2. Good knowledge of Microsoft Office (Word, Excel, PowerPoint, etc.)

Language Skills Required:

1. Italian: Native or professional proficiency, written and spoken (C1)
2. 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