QA Specialist

Role Summary:

• Our client is looking for a Quality Assurance Specialist to join their QA Team based at their busy biopharmaceutical facility in Co. Waterford.
• The successful candidate will be a critical team member, reporting directly to the Quality Compliance Team Leader and will play an integral role within Quality Assurance to support for projects.
• The QA Specialist will work as part of the Quality Assurance Team on site ensuring products are manufactured, stored, and tested in accordance with cGMP.

Core Duties and Responsibilities:

• Provide QA support to new & ongoing projects.
• Review and approval of Change Controls, Deviations, CAPA’s, Protocols, Reports, Quality Events and tasks.
• Acts as Quality Point person for Projects providing guidance / feedback on quality issues.
• Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk.
• Work with relevant departments/project teams to ensure timely closure of quality actions / findings.
• Actively contribute to continuous improvement initiatives
• Conduct duties in a safe manner and report all safety issues or concerns.

Minimum Qualifications and Experience:

• Bachelor’s degree in a science or related dicipline
• Experience in Quality Assurance/Projects preferable
• Proven ability to provide quality expertise and support to the QA team and site teams
• Proven ability to support the delivery of tasks in a highly regulated manufacturing environment
• Good communication skills at organization, team, and individual levels
• Knowledge of requirements for cGMP, US, and EU regulatory requirements
• Full understanding of relevant quality and compliance regulations
• Able to manage projects to plan/budget.
• Effective facilitator

Please note, we do not require agency assistance with this role.