CSV Specialist

Vor 3 Tagen


Bern, Bern, Schweiz Avacone Iberia S.L. Vollzeit
CSV Consultant

We are seeking a skilled CSV Consultant to join our team at Avacone Iberia S.L.

Key Responsibilities

As a CSV Consultant, you will be responsible for:

  • Managing and executing CSV projects for customers in the life science sector
  • Evaluating and creating gap analyses, CSV documents, and data governance
  • Ensuring compliance with relevant regulations, with a focus on data integrity
  • Executing validations on ERP, MES, IT, monitoring, and automation systems, as well as LIMS
  • Creating and processing risk analyses, validation plans, SOPs, changes, deviations, CAPAs, V-plans, and V-reports
  • Commissioning computerized systems and conducting data integrity gap analyses
  • Submitting recommendations and optimizations to ensure GMP compliance
Requirements

To be successful in this role, you will need:

  • An academic education in a scientific, technical, or business administration field
  • At least 5 years of professional experience in GxP compliance
  • Extensive knowledge of GxP compliance or computer system validation
  • Sound knowledge of regulatory requirements, including GxP, Annex 11, Annex 15, 21 CFR Part 11, FDA/EU guidelines, Swiss Medic, and GAMP 5
  • Experience as a project manager for customer projects
  • Independent and reliable working style
  • Strong conceptual and analytical skills, with the ability to develop sustainable and pragmatic solutions
  • Fluency in written and spoken German and English
  • Appropriate mobility and flexibility

We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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