Computerized Systems Validation Specialist

2 meses atrás


Lisboa, Lisboa, Portugal Hovione Tempo inteiro

About the Role

Hovione is an independent family-owned international group of companies dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. We are seeking a highly skilled Computerized Systems Validation Specialist to join our team.

Key Responsibilities

  • Define and implement procedures and processes to ensure Hovione facilities, equipment, and supporting systems are fit for purpose and comply with applicable quality standards.
  • Work collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application.
  • Apply and develop knowledge of Quality's Computerized Systems and participate in area processes, procedures, and projects of computerized system developed in-house or off-the-shelf.
  • Support the evaluation of design documents against regulatory and Hovione compliance requirements.
  • Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity, and product quality.

Requirements

  • University or equivalent qualification in Chemistry, Chemical Engineering, or similar scientific field.
  • Requires educational/training experience in Computerized Systems Validation.
  • Knowledge of software testing, quality systems, and validation principles.
  • Fluency in English is a requirement.


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