JO-2410-542775
Quality Assurance Specialist - NPI Projects
Reporting to the site QA Manager
Midlands – Co Laois, commutable from Offaly, Kildare, North Tipperary and surrounds.
CPL are working with our client partner to hire an experienced Quality Assurance Specialist for their GMP certified chemical production facility in Laois. The plant has been purpose built to support their client portfolio who are primarily in the Bio- Pharma, General Pharma and API manufacturing industries. Due to increased business, they require a QA Specialist to support a variety of commercialization/ NPI projects on-site
Role
- A key member of the product commercialization/NPI team.
- Lead the quality processes and product validation processes for product commercialization/NPI (New Product Introduction).
- Responsible for evaluating 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 providing 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.
- Responsible for updating/creating/review and approval of validation protocols and reports.
- Responsible for meeting agreed timelines for product commercialization/NPI projects.
- Review packaging specifications ensuring product contact packaging meets customer, regulatory and compatibility requirements. (i.e., leachable, extractables)
- Responsible for label management for new products.
- Provide regular project updates to management
- Responsible for escalating QA concerns/issues/challenges to QA Manager
Requirements
- Experience in a Quality Assurance role supporting NPI project required.
- Experience in a regulated environment.
- Previous GMP experience essential
