Process & Computer System Validation Specialist (Gcp)...

1 settimana fa

Siena, Italia Philogen A tempo pieno

Job Title: PROCESS & COMPUTER SYSTEM VALIDATION SPECIALIST (GCP)Department: QAPhilogen 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)RoleThe 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 ********.Our recruitment adheres to the provisions of Legislative Decree ********, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.#J-*****-Ljbffr

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