Computerised System Validation (CSV) Specialist - Austria (open to relocators)

* 1 year contract role *

** Fully office based near Vienna, Austria **

*** Role open to relocators ***

Main responsibilities

  • Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information System
  • Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
  • Translate technical information and requirements into qualification/validation test design

Qualification and Experience

  • Bachelor’s Degree; scientific background preferred
  • At least 2 years of pharmaceutical of FDA related validation experience
  • Good knowledge of GMPs, 21CFR Part 11, USP 1058 – and other relevant industry regulations and guidance
  • Strong interpersonal skills and demonstrated ability work independently
  • Self-directed and motivated individual who is able to operate in a rapidly changing business environment
  • Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
  • Ability to Build consensus among team of stakeholders
  • Excellent critical thinking/analytical and problem solving skills

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