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Validation Expert

2 mesi fa

Rieti, Lazio, Italia Takeda A tempo pieno
Job Description

Overview

Takeda is seeking a highly skilled Validation Expert to join our team. As a key member of our Quality Control department, you will be responsible for ensuring the accuracy and reliability of our computer systems and analytical instruments.

Key Responsibilities

  • Validation Planning and Execution
    • Develop and implement validation plans for computer systems and analytical instruments
    • Ensure compliance with regulatory requirements, including 21 CFR Part 11 and EU Annex 11
  • Validation Documentation and Reporting
    • Prepare and maintain accurate and detailed validation documentation
    • Provide regular reporting on validation progress and results
  • Collaboration and Communication
    • Work closely with cross-functional teams, including Quality, IT, and Operations
    • Communicate effectively with stakeholders to ensure seamless validation processes

Requirements

  • Education
    • Master's degree in Science (Chemistry, Pharmaceutical Chemistry, or Biology/Biotechnology and engineering)
  • Experience
    • Three years of experience in Computer System Validation (CSV)
  • Skills
    • Proven knowledge of quality control and regulatory requirements
    • Excellent communication and problem-solving skills
    • Ability to work in a fast-paced environment and prioritize multiple tasks

About Takeda

Takeda is a global pharmaceutical company committed to delivering innovative medicines and services to patients worldwide. We are a patient-focused company that values diversity, inclusion, and collaboration.