Quality Assurance Analyst

Summary:
Our client, a biopharmaceutical company based in Waterford, requires a QA Analyst who will join the Quality Assurance team to support Operations areas. This team ensures products are manufactured, stored, and tested in accordance with cGMP. This role might required to work on shift.

Responsibilities:

• Participate in the preparation and review of batch documentation.
• Review and approval of deviation, CAPA’s, quality events and tasks.
• Ensure the quality system is effectively implemented and maintained.
• Acts as Quality Point person for systems / processes 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 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.

Qualifications & Experience:

• Bachelor’s degree in a science related discipline.
• 1 year working experience in a relevant role.
• Experience in quality in operations is preferable; in particular strong understanding in the management, manufacture, and release of product.
• 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.