This business is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging. The businesses purpose is placed around human cooperation at the heart of the organisation's relationships and actions. A pioneer for 95 years in the field of contrast media, this businesses team consists of over 2,600 people globally, continuously innovating with 10% of revenue dedicated to Research & Development across four centres around the world including a state of the art manufacturing plant here in Ireland whcih is responsible for manufacturing all API for one of the organisations most strategically important products.
Responsibilities
Lead the GMP compliance efforts for a Pharma production process related to the site.
Promote the organisation's culture of quality (1Quality) and continuous improvement across the organization.
Monitor and audit manufacturing for GMP compliance and serve as a key contact to production regarding quality and compliance issues.
Develop, manage, and maintain appropriate procedures to ensure regulatory compliance.
Establish and maintain key quality indicator elements, organize quality goals and objectives.
Identify, assess and incorporate best demonstrated industry practices to assure GMP and regulatory compliance with all relevant Health Authorities (HA) and applicable external regulatory requirements and applicable guidance documents.
Assure that Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies.
Manage any third parties to which functions have been outsourced.
Promote and communicate the Company Quality Plan and all associated policies and guidelines.
Maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements.
Improving operational performance of QA and QC departments by coaching team members.
Manage and support all HA and other regulatory agency activities including inspections, inquiries, notifications, all and other agency associated activities.
Apply modern principles of quality systems and strategic planning to products and processes to achieve sustainable quality and compliance performance.
Establish and/or improve monitoring measures for key elements related to quality goal attainment.
Analyze and report product and process quality trends, and quality system integrity against internal and external guidelines, standards and regulations.
Supervise Quality Assurance, Quality Control, Drug Product Release and Training functions.
Develop and conduct training for quality and other personnel, as necessary. Ensure that quality department personnel are trained to perform their jobs effectively and ensure an efficient operation that is well integrated.
Recognize the need for investigation due to deviation from written procedures, conduct investigation into non-conformance, incidents/deviations and recommend disposition of the affected product/component.
Prepare trend reports related to in-process monitoring, deviation reports, investigation reports. Follow up with functional department for timely completion of corrective and preventive actions recommended.
Define/Perform annual and random audits of production, warehouse, maintenance, analytical laboratory, etc.
Recommend continuous improvement plans based on observation of process, vendors, data, etc. to management.
Ensure timely in-process/final testing of drug products.
Notify any problems with in-process testing results to production immediately and investigate the incident, as appropriate.
Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.
Perform personnel evaluation as needed.
Develop and manage the financial budgets for overhead and staffing.
Perform other related duties as assigned from time to time based on company needs.
Experience
Bachelor's Degree in chemistry, engineering, pharmacy or related Scientific qualification.
Ten years' experience in a pharmaceutical Quality Assurance/Quality Control environment.
Five years of progressive leadership or supervisory experience in a Quality Assurance function of the pharmaceutical industry required.
Demonstrated ability to implement continuous improvement methods to improve quality and operations performance. Six Sigma / Lean experience or qualification an advantage.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.
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