CSV & Data Integrity 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. 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.