Quality Systems Specialist

Role Summary:

• A new vacancy has arisen for a Quality Systems Specialist to join our client’s Quality Systems Team based at their busy biopharmaceutical facility in Co. Waterford.
• The Quality Systems Specialist will ensure that effective quality systems are implemented meeting industry standards and all cGMP requirements.
• The successful candidate will report to the Quality Systems Team Leader and support the Manufacturing areas and all support departments.
• Interface with other Sites within the company network, as appropriate.

Core Duties and Responsibilities:

• Ensure all appropriate Quality Systems are in place for the site meeting cGMP, Corporate Standards and industry best practise.
• Perform critical/constructive review of procedures on site.
• Identify Improvements and Lead Projects to make step change improvements to site quality systems.
• Actively contribute to continuous improvement initiatives at the site.
• Conduct all activities in a safe manner and report all safety issues and/or concerns.
• Attends team meetings, regular 1:1’s, support owns goals and team goals and actively manages own performance development.
• Define, manage and maintain key metrics for Site Quality Systems ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities.
• Manage and support Quality Systems on Site as appropriate and/or other electronic quality tools.
• Co-ordinate all Complaints from customers and other company sites ensuring they are appropriately logged, investigated, reported and trended ensuring collaboration with Regulatory and QP function.
• Manage and continuously improve the Site Vendor Program incorporating Auditing, Complaint management, Quality Technical Agreement, Supplier File and Risk assessment where appropriate.
• Manage, direct and support the Site Self Inspection Program (Internal Audit & Walkthrough Program)
• Manage and improve the Site audit Readiness Program with cross functional ownership, effectively leading all external regulatory and corporate audits at the Co. Waterford site.
• Lead and direct change management on the site continuously gaining feedback for improvement.
• Supporting and providing appropriate information to support Product Performance Reviews (PPR)
• Ensure compliance to cGMP at all times.

Minimum Qualifications and Experience:

• Third level qualification (degree in science or related discipline)
• Minimum of 2/3 years’ experience in a similar role Pharmaceutical or sterile Manufacturing experience would be an advantage.
• Very good knowledge of cGMP in a regulated environment.
• Excellent accuracy and attention to detail.
• Strong Planning/Organising skills.
• Proven and effective Project Management skills.
• Customer Focus Driven with excellent interpersonal skills.
• Excellent communicator with Good Presentation skills.
• Working knowledge of computer systems.
• Personal development and goal management skills.
• Flexible and adaptable- comfortable and open to change.
• Works well across all levels of the organisation, multi-site and multi-national environment.
• Works on own initiative in a Self-Directed manner with minimal supervision.
• Highly motivated and focuses on achieving results.
• Takes personal responsibility for own development and actions.

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