Computerized Systems Validation Specialist
2 meses atrás
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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