Quality Assurance Specialist - NPI Projects
We are seeking an experienced Quality Assurance Specialist to join our client partner's GMP certified chemical production facility in Laois.
This is a key role within the product commercialization/NPI team, responsible for leading quality processes and product validation processes for new products.
The successful candidate will have experience in a regulated environment and previous GMP experience is essential.
Key Responsibilities:
* Evaluate new and current processes to determine validation/verification requirements.
* Responsible for risk assessing new/current processes.
* Ensure adequate controls are in place to ensure product quality and reduce risk of non-conforming product.
* Manage project related non-conformances' and provide support to all other departments in relation to investigation of issues identified as part of projects.
* Responsible for managing and supporting project related CAPA's.
* Provide QA decisions for Product Commercialization Process.
* Review packaging specifications ensuring product contact packaging meets customer, regulatory and compatibility requirements.
* Responsible for label management for new products.
* Provide regular project updates to management.
Requirements:
* Experience in a Quality Assurance role supporting NPI project required.
* Experience in a regulated environment.
* Previous GMP experience essential.
Salary: Estimated €60,000 - €80,000 per annum.