Team Horizon is seeking a QP & Quality Manager to play a crucial role in maintaining top quality and compliance in manufacturing processes for our client's facility in Dublin.
This opportunity lets you work in a dynamic environment - passionate about innovation and excellence.
You will lead efforts to ensure our products meet strict European Legislation and company standards.
Why you should apply:
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
What you will be doing:
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 *******/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
What you need to apply:
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.
#J-*****-Ljbffr