CSV Specialist

AziendaBSP Pharmaceuticals Sede Latina, Italia Professione/ Funzione Qualità

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

To expand its workforce, BSP Pharmaceuticals is seeking candidates for opportunities within the CSV & Data Integrity area

Responsibilities:
Drafting and execution of validation documents for laboratory and production computer systems (analytical instrumentation, HMI, SCADA...)

Validation Plan

System Configuration

Validation protocols (IQ/OQ/PQ)

Traceability Matrices

Reports

Performing testing activities of laboratory and production computerized systems.

Performing periodic reviews of computerized systems

Reviewing vendor documents

Participation in SAT and FAT

Collaboration in writing departmental SOPs and the Validation Master Plan for computerized systems

Requisiti

Experience in Computer System Validation

Master's degree in a scientific disciplines

Thorough knowledge of 21 CFR Part 11 and Annex 11 regulations and Data Integrity principles.

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.