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Excellent QP role with one of our Galway based pharmaceutical clients. This is a permanent role with excellent salary and benefits package. This is also a full time on site role. Please get in touch for more information on this QP role, and other options we have open nationally.

• Perform QA/QP batch release as required to support operational business requirements (the job holder is required to be named on the site manufacturing licence as a QP and perform QP batch release of pharmaceutical products to the market in accordance with guidelines of Annex 16 of EU GMP guide and relevant legislation 2001/83/EC & 2001/82/EC.
• Responsible for the release of medical device finished products to market as per relevant approved procedures.
• Provide technical expertise for all QA and compliance topics/issues as required.
• Provide QA input into relevant Risk Management programmes within the company and to utilise risk management tools to support science based decision making in support of the highest product quality, safety and efficacy standards.
• Assist with development and implementation of effective performance monitoring indicators for the Quality Assurance department.
• Perform timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.
• Provide support for deviation investigations, including root cause analysis and corrective and preventative action (CAPAs) proposals and initiatives.
• Ensure relevant QA documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions.
• Actively contributes to continuous improvement activities.
• Deputise for the Quality Assurance Operations Manager as required.
• Perform any other duties as assigned.

Skills & Experience

• Experience of all pharmaceutical/medical device quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, batch release and management review.
• Ability to handle multiple tasks in a fast paced environment.
• Experience of Quality Engineering and Lean operational systems in manufacturing is beneficial.
• Working management of risk management tools (eg. Hazard Analysis and Critical Control Points and / or Failure Mode Effect Analysis.