CSV Associate

Job Information

• Industry: Pharma/Biotech/Clinical Research

• Salary: 20.000-25.000 euro

• Work Experience: 1-3 years

• City: Verona

• Province: Veneto

• Country: Italy

• Postal Code: 37100

• Hybrid Job: No

About Us

We 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 Description

About the Company:

Arithmos is a leading international Company that operates within the Life Sciences industry & Technology field and establishes itself as a long-standing partner for technology and expert service providers across Clinical, Regulatory, Quality, Pharmacovigilance, and Medical Affairs domains.

With offices in the UK and in Italy, our company helps organizations to gain the best business value through technology-enabled solutions and achieve excellence in business operations.

The role:

We 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.

Requirements

Your 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).

Benefits

Why join us?

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 euro
• Corporate bonus
• Meal vouchers
• Career Development
• Corporate Training