CSV Specialist

BSP Pharmaceuticals S.p.A.; Latina; On-site; EUR 45,000 - 65,000; Full time

Job summary

BSP Pharmaceuticals S.p.A. in Italy seeks a specialist for the CSV & Data Integrity area to advance validation activities of laboratory and production computer systems.

You will draft validation documents, execute IQ/OQ/PQ protocols, maintain traceability matrices, review vendor documents, and contribute to SOPs and the Validation Master Plan in a highly regulated CDMO environment.

Experience with 21 CFR Part 11 and data integrity principles is essential.

Qualifications

• Experience in Computer System Validation.
• Master's degree in a scientific discipline.
• Thorough knowledge of 21 CFR Part 11, Annex 11 and Data Integrity principles.

Responsibilities

• Drafting and execution of validation documents for laboratory and production computer systems.
• 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.

Skills

Computer System Validation

Education

Master's degree in a scientific discipline

Job description

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.