CSV Specialist

7 giorni fa

Verona, Veneto, Italia CPL & Taylor by Synergos Srl A tempo pieno
About the Company

CPL & Taylor by Synergos Srl is a leading international company operating in the Life Sciences industry and Technology field, providing technology-enabled solutions and expert services to organizations across Clinical, Regulatory, Quality, Pharmacovigilance, and Medical Affairs domains.

The Role

We are seeking a CSV Junior Consultant to join our team, responsible for ensuring computer systems are properly validated and maintained in a compliance status through appropriate change control management and periodic review.

Requirements
  • 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)
Key Responsibilities
  • Develop validation strategies and manage GxP system lifecycle documentation
  • Ensure compliance of managed computerized systems to relevant regulatory requirements
  • Ensure project team complies with the CSV methodology
  • Cooperate in the definition of the GxP System Risk Assessment
  • Oversee system change requests and associated documentation
  • Cooperate with the technical team in the investigation into systems and validation incidents
  • Review proposed changes to validated computerized systems
  • Support the Senior CSV Specialist in Client audit and regulatory inspections
Benefits

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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