Process & Computer System Validation Specialist (GCP)
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).
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.
Seniority level
Associate
Employment type
Full‑time
Job function
Other
Industries
Pharmaceutical Manufacturing
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