Qualification Specialist

1 settimana fa

Latina, Italia BSP Pharmaceuticals A tempo pieno

**Descrizione azienda**:
BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry.

BSP has been at the forefront in the fight agains cancer since 2006.

Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant.

We are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs.

The fight against cancer is ours too.

**Posizione**:
**Responsabilità del ruolo**:

- Assicurare l’analisi e la valutazione della documentazione técnica relativa agli impianti ed alle macchine che devono essere sottoposti a qualifica, nel rispetto delle procedure aziendali.
- Assicurare la redazione dei Protocolli di qualifica (Protocolli di IQ-OQ-PQ).
- Assicurare la corretta qualifica degli impianti e macchinari, attraverso l’esecuzione delle attività operative previste dai Protocolli (Protocolli di IQ-OQ-PQ) e il coordinamento e supervisione delle attività svolte dalle altre funzioni aziendali, nel rispetto dei protocolli e delle procedure aziendali.
- Assicurare una corretta analisi delle attività di qualifica, attraverso la raccolta e analisi dei dati e risultati generati, nel rispetto dei protocolli e delle procedure aziendali.
- Assicurare la corretta redazione dei Rapporti di qualifica (Report IQ-OQ-PQ), sulla base dell’analisi dei dati emersi dalle attività di convalida, nel rispetto dei protocolli e delle procedure aziendali.
- Assicurare la corretta archiviazione di tutta la documentazione relativa alle qualifiche, attraverso l’allestimento di dossier di convalida.

**Requisiti**:

- Laurea in Ingegneria, CTF, Farmacia, Chimica.
- Pregressa esperienza nel ruolo all'interno di aziende farmaceutiche di produzione sterile.

**Altre informazioni**:

- At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity, the different backgrounds and experiences and provide equal opportunity for all._
- We are BSP._

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