This organisation is a world-leader in the research & development and production of biotechnology and pharmaceutical products. Their main focus is the production of biologic products and vaccines.
As a Validation Consultant you will work on several projects related to the validation of vaccines manufacturing (computerized) systems.
- Reviews and approves technical reports to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology.
- Ensures that validation, qualification and other life cycle activities are consistent with company validation policies and procedures and federal regulations.
- Evaluate technical problems and provide recommendations for corrective actions.
- Provide coaching and training and guidance on aspects of validations and qualifications.
- Act as a major contact for validation issues during regulatory and third party audits.
- Implementation of projects.
- Min BSc degree. Preferred MSc degree.
- Experience in construction, utility and equipment introduction / software related to the manufacture of Biological Drug Substances.
- Experience in computed system validation (CSV).
For more information contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.