col-wideJob Description:
CPL&TAYLORby Synergos ricerca:
JUNIOR CSV SPECIALIST POSITION
(ComputerSystem Validation)
(Rif. ANN296869)
Job Description
About the Company:
Arithmos is a leading internationalCompany that operates within the Life Sciences industry & Technology fieldand establishes itself asa long-standing partner for technology and expert service providersacross Clinical, Regulatory, Quality, Pharmacovigilance, and Medical Affairsdomains.
Withoffices in the UK and in Italy, our company helps organizations to gain thebest business value through technology-enabled solutions and achieve excellencein business operations.
The role
We are currently looking for a CSV JuniorConsultant to join our team.
We will consider candidates with nolittle or no experience, but who have a keen interest in Computer SystemValidation in Life Science and Pharma.
The aim of the role isto ensure that computer systems areproperly validated and maintained in a compliance status, through appropriatechange 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 knowledgeof 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?
InArithmos we prioritize personal andprofessional growth, offering international opportunities for development andadvancement. You'll have the chance to work on groundbreaking projects thatsignificantly impact global healthcare outcomes, all while collaborating withleading experts in the field. Our flexible work policies support ahealthy work-life balance. Our competitive compensation package is designed toacknowledge and reward your contributions:
•Salary package equivalent to therole held
•Corporatebonus
• Meal vouchers
•Career Development
•Corporate Training
Place of work:Verona (VR)
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