PROCESS & COMPUTER SYSTEM VALIDATION SPECIALIST (GCP)

Experteer Italy; Siena; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

Un'azienda biotecnologica di riferimento in Italia cerca un Process & Computer System Validation Specialist (GCP) per il dipartimento QA. Il candidato sarà responsabile della validazione dei sistemi informatici e della conformità a normative GMP/GCP. Sono richiesti almeno 2 anni di esperienza nel settore farmaceutico e una laurea in discipline tecniche/scientifiche. È un ruole chiave per garantire l'integrità dei dati nel contesto clinico.

Competenze

• Almeno 2 anni di esperienza nel settore farmaceutico, preferibilmente con attività GCP.
• Buona conoscenza della normativa FDA 21 CFR Part 11, EU Annex 11 e ISPE GAMP.

Mansioni

• Validare e mantenere i sistemi informatici secondo le migliori pratiche GxP/GAMP.
• Collaborare con i team QA e clinici per garantire qualità e integrità dei dati.
• Gestire la documentazione di validazione e redigere/rivedere SOPs.

Conoscenze

Proattività

Capacità di risoluzione dei problemi

Orientamento ai risultati

Capacità di lavorare in team multidisciplinari

Formazione

Laurea in discipline tecniche/scientifiche

Strumenti

SOPs

Documentazione di validation

Descrizione del lavoro

PROCESS & COMPUTER SYSTEM VALIDATION SPECIALIST (GCP)

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.

We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.