CSV & Data Integrity Specialist (Pharma)

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

Job summary

BSP Pharmaceuticals S.p. A is expanding its quality and data integrity team to strengthen validation of computerized systems in lab and production environments.

The CSV & Data Integrity role focuses on validation planning, IQ/OQ/PQ execution, system configuration, documentation, and collaboration on SOPs and the Validation Master Plan. A Master’s degree and experience with 21 CFR Part 11 are required.

Qualifications

• 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.

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
• Participation in SAT and FAT
• Collaboration in writing departmental SOPs and the Validation Master Plan for computerized systems

Skills

Validation experience

Data integrity

Regulatory knowledge

Education

Master's degree in a scientific discipline

Tools

SCADA

HMI

IQ/OQ/PQ

Job description

BSP Pharmaceuticals S.p. A is expanding its quality and data integrity team to strengthen validation of computerized systems in lab and production environments.

The CSV & Data Integrity role focuses on validation planning, IQ/OQ/PQ execution, system configuration, documentation, and collaboration on SOPs and the Validation Master Plan. A Master’s degree and experience with 21 CFR Part 11 are required.