GCP Computer Systems Validation Specialist (QA/Pharma)

Philogen S.p.A.; Siena; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading biotech company in Italy is seeking a highly motivated Process & Computer System Validation Specialist (GCP) to join their QA department. The role involves validating computerized systems to ensure compliance with GMP/GCP regulations, contributing to data integrity in clinical environments. Candidates should have a relevant degree, at least 2 years of experience in the pharmaceutical sector, and a good command of English. This is a full-time position offering a dynamic work environment focused on quality and innovation.

Qualifications

• Minimum of 2 years experience in the pharmaceutical sector, preference for GCP activities.
• Knowledge of computerized systems lifecycle and experience with IQ/OQ/PQ qualifications.
• Solid understanding of regulatory frameworks: FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP, MHRA, PIC/S.
• Good command of spoken and written English.

Responsibilities

• Validate and maintain computerized systems in line with GxP/GAMP best practices, focusing on GCP.
• Collaborate with QA and clinical teams to ensure quality and data integrity.
• Manage validation documentation and draft/review SOPs.
• Participate in internal and external audits regarding validation and QA GCP activities.

Skills

Team collaboration

Problem-solving

Proactive attitude

Attention to quality and safety

Education

Degree in technical/scientific disciplines

Job description

A leading biotech company in Italy is seeking a highly motivated Process & Computer System Validation Specialist (GCP) to join their QA department. The role involves validating computerized systems to ensure compliance with GMP/GCP regulations, contributing to data integrity in clinical environments. Candidates should have a relevant degree, at least 2 years of experience in the pharmaceutical sector, and a good command of English. This is a full-time position offering a dynamic work environment focused on quality and innovation.