Quality Manager & QP

• A job where you will find purpose and pride, where your work makes a difference.
• Join a team driven by a culture of courage, trust, and collaboration where you strive for efficient and effective operations
• Competetive Salary & benefits package

• Ensure the site follows Good Manufacturing Practice for Medicinal Products for Human Use. This is according to Eudralex Volume 4 of "The rules governing medicinal products in the European Union." Follow Commission Directive 2003/94/EEC, its amendments, and any company requirements.
• Act as a Qualified Person (QP) responsible for implementing the quality management system. Lead all aspects of the products release process. Ensure strict adherence to regulatory and customer requirements.
• Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential product quality issues.
• Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time.
• Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly.
• Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products.
• Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety.
• Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Report

• 6-10 years’ experience of Quality implementation in Pharma industry
• Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments.
• Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management.
• Proven leadership experience with a track record of consistently meeting results.
• Ability to operate effectively in a fast-paced environment and prioritize multiple tasks.
• Proven ability to manage/supervise a large and diverse team of employees.
• Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective.
• Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making.
• Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other functions.

Team Horizon