POS 2800
Status 11

Senior CSV Manager

Beschreibung: For one of our Pharma clients near Ulm we are seeking freelance support as: Senior CSV Manager (M/F)
  • Planning of time, cost and capacity needs of the validation project
  • Management of project dependencies and delivery risks
  • Ensure the global application landscape (in a worldwide validation status)
  • Development and maintenance of a risk-based validation concept
  • Ensure effective, efficient and complaint validation
  • Representation and defense of the validation approach in front of auditors and regulatory authorities
  • Main contact for the international external validation vendor in regards of the validation concept, material and content related questions
  • Establishment of relevant control mechanisms to ensure the defined quality standards of the validation material
  • Experienced in organizational consulting methods
  • Knowledge of project management tools for international system implementations
  • Knowledge of computer system validation regulations and methods (e.g. CFR21 part 11)
  • Knowledge of process analysis and user requirement engineering methods
  • Must have: CSV/IT-Background
  • Must Have: Business fluency in English
  • Nice to have: German
Bemerkungen: WANTED: Senior Validation Manager (M/F). Contact or +49 (0) 89 18 90 998 47. Skills: CSV & GAMP (Computer System Validation & (Good automated manufacturing), IT Pharma / MedTech, Pharma

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