Process & Computer System Validation Specialist (GCP)

1 settimana fa

Siena, Toscana, Italia Philogen S.p.A. A tempo pieno

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.

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