Process & Computer System Validation Specialist (GCP)

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

Process & Computer System Validation Specialist (GCP)

Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti‑tumor therapies, is looking for a highly motivated and qualified Process & Computer System Validation Specialist (GCP).

Role

The resource will join the QA department and will be responsible for the validation and maintenance of the company’s computerized systems, ensuring compliance with GMP/GCP regulations and quality standards. The role will be pivotal in QA GCP activities, contributing to process compliance and safeguarding data integrity in the clinical environment.

Responsibilities

• Validate and maintain computerized systems in line with GxP/GAMP best practices, with a specific focus on GCP.
• Collaborate with QA and clinical teams to ensure quality and data integrity.
• Manage validation documentation and draft/review SOPs related to computerized systems and equipment.
• Participate in internal and external audits concerning validation and QA GCP activities.Provide technical support and contribute to internal training on computerized systems.

Requirements

• Degree in technical/scientific disciplines.
• At least 2 years of experience in the pharmaceutical sector, preferably with exposure to GCP activities.
• Knowledge of the 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.

Soft Skills

• Ability to work effectively in multidisciplinary teams.
• Proactivity, problem‑solving skills, and result orientation.
• Flexibility, passion for innovation, and strong commitment to quality and safety.

Seniority level

Associate

Employment type

Full‑time

Job function

Other

Industries

Pharmaceutical Manufacturing