Descripción de la oferta
At Astek, we are seeking a Validation Specialista CSV / CSA to collaborate with our partner in the pharmaceutical industry in an international setting
Your mission, should you choose to accept it…
Lead computerized system validation activities in GxP environments
Define and execute validation strategies aligned with CSV and CSA principles
Produce and review validation documentation (URS, FS, DS, IQ/OQ/PQ, risk assessments)
Ensure compliance with regulatory requirements (FDA, EMA, GAMP5)
Promote the transition from the traditional CSV approach to the CSA approach (risk-based and efficiency-driven)
Collaborate with quality control, IT, and business stakeholders
Identify opportunities to optimize validation processes
Who are you?
We are looking for someone with the following knowledge and experience:
More than 5 years of experience in computer system validation (CSV) and emerging computer software assurance (CSA) practices.
Proven experience in validation within the pharmaceutical sector (CSV required).
Clear understanding of CSV versus CSA.
Solid knowledge of GxP, GAMP5, and regulations.
Fluency in English and strong collaboration skills in international teams
Our style is to have flexible schedules and highly value the well-being of our employees.
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