Process & Computer System Validation Specialist (GCP)
Philogen S.p.A. ·
ph3Process Computer System Validation Specialist (GCP) /h3 pPhilogen 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). /p h3Role /h3 pThe 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. /p h3Responsibilities /h3 ul liValidate and maintain computerized systems in line with GxP/GAMP best practices, with a specific focus on GCP. /li liCollaborate with QA and clinical teams to ensure quality and data integrity. /li liManage validation documentation and draft/review SOPs related to computerized systems and equipment. /li liParticipate in internal and external audits concerning validation and QA GCP activities.
Provide technical support and contribute to internal training on computerized systems. /li /ul h3Requirements /h3 ul liDegree in technical/scientific disciplines. /li liAt least 2 years of experience in the pharmaceutical sector, preferably with exposure to GCP activities. /li liKnowledge of the computerized systems lifecycle and experience with IQ/OQ/PQ qualifications. /li liSolid understanding of regulatory frameworks: FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP, MHRA, PIC/S. /li liGood command of spoken and written English. /li /ul h3Soft Skills /h3 ul liAbility to work effectively in multidisciplinary teams. /li liProactivity, problem‑solving skills, and result orientation. /li liFlexibility, passion for innovation, and strong commitment to quality and safety. /li /ul h3Seniority level /h3 pAssociate /p h3Employment type /h3 pFull‑time /p h3Job function /h3 pOther /p h3Industries /h3 pPharmaceutical Manufacturing /p /p