Process & Computer System Validation Specialist (Gcp)...
3 giorni fa
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)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.
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GCP Process
32 minuti fa
siena, Italia Philogen A tempo pienoA biotech company in Tuscany is seeking a Process & Computer System Validation Specialist (GCP) to validate and maintain computerized systems, ensuring compliance with GMP/GCP regulations. The ideal candidate has a technical/scientific degree and at least 2 years of experience in the pharmaceutical sector. Responsibilities include managing validation...
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Siena, Italia Philogen S.P.A. A tempo pienoProcess & 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).RoleThe resource will join the QA department and will be...
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PROCESS & COMPUTER SYSTEM VALIDATION SPECIALIST (GCP)
2 settimane fa
Siena, Italia Philogen A tempo pienoJob Title: PROCESS & COMPUTER SYSTEM VALIDATION SPECIALIST (GCP) Department: QA 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...
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Process & Computer System Validation Specialist (Gcp)
1 settimana fa
Siena, Italia Philogen A tempo pienoJob 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 qualifiedProcess & Computer System Validation Specialist (Gcp)RoleThe resource will join theQA...
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Siena, Italia Philogen S.p.A. A tempo pienoPhilogen 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...
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Siena, Italia Philogen S.p.A. A tempo pienoPhilogen 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...
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siena, Italia Philogen S.p.A. A tempo pienoPhilogen 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...
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Siena, Italia Philogen S.P.A. A tempo pienoPhilogen 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...
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Siena, Italia Philogen S.p.A. A tempo pienoPhilogen 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...
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Siena, Italia Philogen S.p.A. A tempo pienoPhilogen 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...
