Dettagli della offerta

Industry: Pharma/Biotech/Clinical Research Work Experience: 1-3 years Province: Veneto Postal Code: 37100 Hybrid Job: No About UsWe are experts in the Life Sciences industry & Technology. We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance, and Medical Affairs domains. We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.
Job DescriptionWe are currently looking for a CSV Associate to join our team. The ideal candidate is able to ensure that computer systems are properly validated and maintained in a compliance status, through appropriate change control management and periodic review. RequirementsYour Responsibilities:
Develop validation strategies and manage GxP system lifecycle documentation, including: planning, requirements and system design documents, Testing Protocols, System release and maintenance documents in accordance with GAMP5 and internal SOPs.Ensure compliance of managed computerized systems to relevant regulatory requirements (e.g. cGMP/GCP/GAMP, Data Integrity) ensuring the completeness and consistency of systems life cycle documentation.Ensure project team complies with the CSV methodology.Cooperate in the definition of the GxP System Risk Assessment liaising with management and system stakeholders.Oversee system change requests and associated documentation.Cooperate with the technical team in the investigation into systems and validation incidents in order to define and implement appropriate solutions.Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system's validation status.Support the Senior CSV Specialist in Client audit and regulatory inspections.Your Background and Experience:
You hold a bachelor's degree in Scientific Subjects and have a minimum of 1 year experience in an equivalent role.A fluent level of English is a must.You have an in-depth knowledge in Life Science and Pharma.You have an in-depth knowledge of computer information requirements legislation (privacy regulations).In Arithmos, we prioritize personal and professional growth, offering international opportunities for development and advancement. You'll have the chance to work on groundbreaking projects that significantly impact global healthcare outcomes, all while collaborating with leading experts in the field. Our flexible work policies support a healthy work-life balance. Our competitive compensation package is designed to acknowledge and reward your contributions:
Salary Package from 20.000 to 25.000 euroCorporate bonusCorporate Training
#J-18808-Ljbffr


Salario Nominale: Da concordare

Risorsa: Jobleads

Funzione Lavorativa:

Requisiti

Global Agile Manager

Global Agile Manager City: Genova Location: Genova, IT, 16128 Contract Type: Permanent Division: Global Operational & Organizational Excellence Level of expe...


Rina Piraeus Team - Liguria

Pubblicato a month ago

Manager In Training (M/F/X)

Riesci sempre a trasmettere la motivazione giusta? Allora questa è l'opportunità che fa per te! I responsabili di filiale sono i leader di una squadra affiat...


Hofer Kg - Liguria

Pubblicato a month ago

Shift Maintenance Manager_Sede Di Arlon (Belgio)

Gi Group SpA is seeking a highly skilled and motivated SHIFT MAINTENANCE MANAGER to join the team at the Ferrero Plant in Arlon (Belgium). THE ROLE: The Shif...


Gi Group S.P.A - Liguria

Pubblicato 13 days ago

Vice Store Manager Castelnuovo Del Garda

MD SPA è un'azienda in forte crescita ed espansione che investe tanto nella formazione e crescita professionale delle risorse interne. MD non soltanto è il l...


Md S.P.A. - Liguria

Pubblicato 13 days ago

Built at: 2024-12-23T14:05:28.411Z