**Location: Siena - Italy** **Department: QA** 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. **Main 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.

📌 Process & Computer System Validation Specialist (Gcp) (Siena)
🏢 Philogen
📍 Siena