CSV Validation Specialist

vor 2 Monaten


Bern, Bern, Schweiz Consultys Vollzeit
Job Description

At Consultys, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring that our business processes are qualified and maintained in a validated state.

Key Responsibilities
  • Provide input on the improvement of testing documentation to ensure compliance with regulatory requirements.
  • Support the implementation and adoption of our global CSV program and remediation efforts.
  • Collaborate with IT and Site organizations to ensure that Computerized System Validation packages are consistent with validation plans and standard operating procedures.
  • Participate in audits and continuous improvement efforts to maintain a high level of quality and compliance.
Requirements
  • Master's Degree or Bachelor's degree in Computer Science, Life Sciences, Engineering, Biotechnology, or Automation.
  • At least 10 years of experience in CSV in the Pharma or Biotech industry.
  • Great understanding of CSV regulations such as FDA's 21 CFR Part 11 and EMA's Annex 11.
  • Experience in modern and risk-based validation executions.
  • Background in Pharma/Biotech industries.
  • Direct experience with LIMS or Laboratory systems is a plus.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced CSV Validation Specialist looking for a new challenge, please submit your application.



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