Process & Computer System Validation Specialist (GCP)

Philogen S.p.A.; Siena; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading biotech company in Tuscany is seeking a Process & Computer System Validation Specialist (GCP) to ensure compliance with GMP/GCP regulations and quality standards. You'll validate computerized systems, collaborate with QA teams, manage documentation, and participate in audits. The ideal candidate has a degree in a technical field, with at least 2 years' experience in the pharmaceutical sector, and a strong understanding of regulatory frameworks. This full-time position offers a dynamic work environment focused on innovation and quality.

Competenze

• At least 2 years of experience in the pharmaceutical sector, preferably with exposure to GCP activities.
• Knowledge of the computerized systems lifecycle.
• 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.

Mansioni

• 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.

Conoscenze

Proactivity

Problem-solving skills

Ability to work in multidisciplinary teams

Flexibility

Commitment to quality and safety

Formazione

Degree in technical/scientific disciplines

Strumenti

IQ/OQ/PQ qualifications

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).

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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