QUALITY ASSURANCE SPECIALIST
The Quality Assurance Specialist role supports the introduction and execution of new products and drug substance into the Carlow facility.
The QA Specialist (NPI and DS) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities.
1) Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
2) Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
3) Ensure that objectives are effectively achieved, consistent with Merck's requirements to ensure compliance, safety and reliable supply to our customers.
- Bachelors Degree or higher preferred; ideally in a related Science discipline
- Experience in a manufacturing, preferably in a GMP setting
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Knowledge of cGMP and GDP preferred
For more imforamation send your CV to firstname.lastname@example.org