On behalf of our client, a Dublin based company, we are currently recruiting for a Senior Quality Specialist role. This is a permanent, full-time position. The role is hybrid with 2 days a week on-site and 3 days remote.
The Senior Quality Specialist MIA role will provide quality operational oversight of the MIA and Compounding function, ensuring compliance with regulatory standards and driving continuous improvement. This role is critical in maintaining product integrity, patient safety, and operational excellence while fostering a culture of quality and collaboration.
The Senior Quality Specialist role will proactively collaborate across teams, seek and apply feedback constructively, and inspire positive change in alignment with organisational values.
Key Responsibilities
Quality Compliance & Regulatory Oversight
- Named as the person responsible for Quality Control on the HPRA’s manufacturers authorisation
- Accountable for the MIA activities for Parental Nutritional PN product
- Ensure the Quality Management System (QMS) meets internal and external requirements, including EU regulations, HPRA GDP/GMP guidelines, and corporate standards.
- Accountable for the quality compounding function, ensuring adherence to all compliance obligations.
- Champion a culture of continuous improvement across processes and systems.
- Preparation, attendance and liaising with HPRA and corporate inspectors during audits. Implementation of corrective actions and submission of final reports.
- Support WDA function, Quality Management System for the Dialysis Care Services and the maintenance of the ISO 13485 standard.
MIA Activities
Responsible for daily MIA activities for Parenteral Nutrition (PN) products.
Ensure handling, order processing, and approval of patient scripts in compliance with MIA requirements.
Review and approve Spanish patient scripts from site in Spain and maintain accurate patient ID logs.
Coordinate CAPA investigations for deviations impacting product quality.
Manage stability testing schedules and data to support expiry dates.
Review and co-ordinate any CAPA investigations for deviations at the Spanish site which may impact on product quality for products supplied.
Assigning resources to all investigations, ensuring the acquisition of the necessary information.
Co-ordinate customer and supplier complaints - including investigations, reporting, and trending.
Ensure the management of the SAP disposition of non-conforming products.
Co-ordinate Mock recalls under the MIA and follow up on all other actions generated.
Ensuring that customer complaints are dealt with effectively and responsible for escalating any relevant complaints to the Qualified Person or competent authority.
Approving and subcontracting activities that may impact on GDP/GMP.
Oversight of the Quality Review Board meetings.
Ensuring the Annual Product Review is completed for MIA products.
Maintain the schedule for stability testing of MIA products and responsible for raising deviations in the event of out of specification (OOS) during stability testing.
Management of the stability data for the support of the expiry dates.
Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with GMP and GDP.
Responsible for internal audits of GMP systems, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken.
Maintaining copies of the approved Specifications in the Document Management system.
Assisting Process Owners in assessing risks and assigning counteractive measures.
Documenting and managing relevant change controls through to completion.
Ensuring implementation, closure and effectiveness of all Corrective & Preventive Actions generated.
WDA, Dialysis Care Services and ISO 13485 Quality Management System
Support of processes related to the Wholesale Distribution Authorisation, ISO 13485 Quality Management System and Dialysis Care Services QMS.
Qualifications and Experience:
- Bachelor’s degree or higher
- Strong knowledge of GMP, GDP, ISO 13485:2016, ISO 9001:2008 and EU pharmaceutical regulations
- Demonstrated ability in quality systems management
- Knowledge of Industry Best Practices for quality and compliance related topics
- Hands on experience in managing multiple stakeholders
- Innovative Problem Solving/Analysis
- A proactive and collaborative work style and the ability to work with multiple priorities and deadlines
- Proven decision-making capability with accountability and responsibility
- Experience in compounding validation activities and SAP experience an advantage
- Background in Pharmacy an advantage.
The ideal candidate will have 5 years’ experience in a pharmaceutical/regulated background with strong working knowledge of compounding, MIA, GMP, WDA and regulatory expectations.
Salary €60-€65k DOE, plus excellent benefit package
For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail ldunne@thornshaw.com