Our customer is one of the biggest producers of vaccines in the world. The company uses its extensive and innovative technology to combat life-threatening diseases such as Corona, HIV and Ebola.
Reviewing and approving technical reports and other sources of information to ensure that validations and procedures are consistent with the company policies and federal regulations. The main focus areas are construction, utility and equipment introduction / software related to the manufacture of Biological Drug Substances (vaccines).
- Ensures that validation, qualification and other life cycle activities are consistent with company validation policies
- Evaluates technical problems and provides recommendations for corrective actions
- Acts as a major contact for validation issues during regulatory and third party audits
- Participates in company meetings related to changes in processes, process improvements, provide suggestions
- HBO/BSc Degree
- At least 10 years of relevant experience in QA
- Up to date GMP, FDA, IGJ knowledge and experience
- Validation, qualification and automation experience
- Experience in CSV and biologics are advantages
For more information please apply via the button below!