CSV Specialist

BSP Pharmaceuticals S.p.A.; Latina; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

BSP Pharmaceuticals S.p.A. is expanding its CSV & Data Integrity team to validate laboratory and production computer systems, including analytical instrumentation, HMI, and SCADA.

The role focuses on drafting validation documents, planning, and execution of IQ/OQ/PQ, with strong emphasis on compliance with 21 CFR Part 11 and data integrity principles. The ideal candidate holds a Master's degree in a scientific discipline and has experience in GMP environments, ready to contribute to the

Competenze

• Must have hands-on experience in validating computer systems used in labs and production.
• Thorough knowledge of 21 CFR Part 11 and Annex 11 regulations and data integrity principles.
• Master's degree in a scientific discipline is required.

Mansioni

• Drafting and execution of validation documents for laboratory and production computer systems (analytical instrumentation, HMI, SCADA).
• Develop and execute Validation Plans and Protocols (IQ/OQ/PQ).
• Maintain traceability matrices and generate validation reports.
• Review vendor documents and participate in SAT and FAT activities.
• Collaborate in SOP writing and in the Validation Master Plan for computerized systems.

Conoscenze

Computer System Validation

Data Integrity

21 CFR Part 11

Formazione

Master's degree in scientific disciplines

Strumenti

IQ/OQ/PQ

Descrizione del lavoro

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 areaResponsibilities:

• 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.