Process & Computer System Validation Specialist (GCP)

Fintech District; Lucca; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading biotech company in Italy seeks a Process & Computer System Validation Specialist (GCP) to join the QA department. This role involves validating and maintaining computerized systems, ensuring compliance with GMP and GCP regulations, and supporting QA activities. The ideal candidate holds a technical degree, has a minimum of 2 years of experience in the pharmaceutical sector, and possesses knowledge of relevant regulatory frameworks. Strong problem-solving skills and teamwork are essential for this position.

Competenze

• Minimum 2 years of experience in pharmaceutical sector.
• Solid understanding of FDA 21 CFR Part 11 and EU Annex 11.

Mansioni

• Validate and maintain computerized systems according to GxP/GAMP.
• Collaborate with QA and clinical teams for quality and data integrity.
• Manage validation documentation and draft/review SOPs.

Conoscenze

Experience in the pharmaceutical sector

Exposure to GCP activities

Ability to work in multidisciplinary teams

Problem-solving skills

Proactivity

Formazione

Degree in technical/scientific disciplines

Strumenti

Knowledge of computerized systems lifecycle

Descrizione del lavoro

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.

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

Industry: Pharmaceutical Manufacturing