CPL&TAYLOR by Synergos ricerca:
JUNIOR CSV SPECIALIST POSITION (Computer
System Validation)
(Rif. ANN296869) 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 Junior
Consultant to join our team. We will consider candidates with no
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 CVS
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.
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 equivalent to the
role held
• Corporate
bonus
M eal vouchersCareer DevelopmentCorporate Training Place of work: Verona (VR) Verifica sul nostro sito
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