JUNIOR CSV SPECIALIST POSITION

2 settimane fa

Verona, Italia SYNERGOS Srl A tempo pieno

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 Junior Consultant to join our team.

We will consider candidates with little or no experience, but who have a keen interest in Computer System Validation in Life Science and Pharma.

The aim of the role is to ensure that computer systems are properly validated and maintained in a compliance status, through appropriate change control management and periodic review.

Requirements

Your Background and Experience:

  • You hold a bachelor’s degree in Scientific or IT Subjects.
  • Recent graduate with little or no experience in CSV.
  • A fluent level of English is a must.
  • You have an in-depth interest in Life Science and Pharma.
  • You have an in-depth knowledge of computer information requirements legislation (privacy regulations).

You will learn to:

  • 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.

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 equivalent to the role held
• Corporate bonus
• Meal vouchers
• Career Development
• Corporate Training

Place of work: Verona (VR)

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