Validation Manager

hace 2 semanas


Sant Cugat del Vallès, España Next-Link A tiempo completo
We are seeking a highly motivated and experienced Validation Manager to join our team, providing expert services to a leading pharmaceutical client.

Main tasks and responsibilities:
  • Develop and document validation strategies for complex projects, considering both business needs and regulatory requirements (GxP, FDA, etc.).
  • Define and implement validation approaches to meet project specifications, collaborating with the client's internal Quality department.
  • Champion the One Medicine Platform's adoption of the DevOps Model within the validation framework.
  • Lead and coordinate the validation process, effectively communicating and negotiating deliverables with stakeholders.
  • Prioritize tasks and manage time effectively to ensure timely project completion.
  • Present and defend validation concepts to compliance offices and regulatory authorities during audits and inspections.


Requirements
  • Bachelor's or Master's degree in IT, engineering, sciences, pharmaceuticals, biotechnology, or a related field.
  • Strong understanding of analysis and user requirement engineering methods.
  • Excellent written and verbal English communication skills.
  • Experience in project implementation using computer validation regulations and methods (SOPs, GCP, FDA Guidelines, CFR 21 Part 11) and data integrity principles.
  • Passion for teamwork and fostering collaboration in diverse technical and cultural environments.
  • Prior experience with Agile methodologies is a strong asset.



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