Quality Specialist - Dublin 12/hybrid

Quality Specialist - Dublin 12/hybrid

Role Overview:
As a Quality Assurance Specialist, your primary duties will revolve around maintaining and enhancing the quality systems to ensure compliance with industry standards, regulatory requirements, and internal procedures. You will work closely with the Quality Manager and other key stakeholders to ensure the company's products meet the required Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.

Key Responsibilities:

• Support Compliance Efforts: Assist the Quality Manager and Qualified Person in ensuring adherence to GMP, GDP, Quality Systems, and both local and international regulations.
• Continuous Improvement Projects: Contribute to the development and execution of continuous improvement initiatives within the Quality Department, especially as the company grows its compounding services division.
• Quality Procedure Updates: Collaborate with operational staff to define and regularly update Quality Procedures, ensuring alignment with regulatory and industry standards.
• Quality Review Board Preparation: Gather and organize data for presentations and discussions at Quality Review Board meetings.
• Internal Audits: Participate in the auditing of GMP/GDP systems, ensuring corrective actions are effectively planned, implemented, and assessed for long-term effectiveness.
• Training & Compliance: Educate personnel on updated GMP/GDP documentation and ensure understanding of the Quality Management System (QMS).
• Incident Reporting: Document, investigate, and report any deviations or incidents to the Quality Manager and Qualified Person, helping to resolve issues promptly.
• Risk Management: Assist in risk assessments and the development of countermeasures with relevant process owners.
• Supplier Audits: Conduct audits and assessments of suppliers to ensure compliance with quality standards.
• Technical Agreement Management: Oversee the management and updates of Technical Agreements to ensure they remain current.
• Change Control Management: Handle documentation and execution of change control processes, ensuring completion and compliance.
• Stability Monitoring: Oversee the stability schedule and manage data related to stability, supporting accurate expiry dates.
• Complaint Management: Coordinate and investigate customer and supplier complaints, including compiling reports and identifying trends.
• Product Recalls: Assist with the coordination and documentation of product recalls, including conducting mock recalls.
• Support Regulatory Activities: Provide support for Pharmacovigilance, Medicovigilance, and overall compliance as needed.
• Protocol Management: Issue protocol and report numbers while maintaining associated logs.
• Report Compilation: Prepare and deliver reports within designated timeframes.
• Resource Allocation for Investigations: Ensure that necessary resources are assigned to investigations and that sufficient information is obtained.
• Corrective & Preventive Actions: Monitor the implementation, closure, and effectiveness of Corrective and Preventive Actions (CAPAs).

Reporting Line:
Reports directly to the Quality Manager.

Qualifications and Requirements:

• Education: Bachelor’s degree in a scientific discipline is preferred.
• Experience: A minimum of 3 years’ experience in quality system roles within FDA and/or EU regulated environments, ideally in manufacturing or distribution.
• Pharmaceutical Knowledge: Solid understanding of EU quality-related pharmaceutical regulations and familiarity with Manufacturing Import Authorisation (MIA) environments.
• Regulatory Knowledge: Understanding of local regulations and industry best practices related to quality and compliance.
• Attention to Detail: Strong organizational skills and a high level of accuracy in handling technical and regulatory information.
• Communication: Strong verbal and written communication skills in English, with proficiency in report and policy writing.
• IT Skills: Proficient in Microsoft Office and relevant job-specific computer applications, including electronic validation systems.
• Problem Solving: Demonstrated ability to analyze problems and make decisions while ensuring accountability.
• Teamwork & Independence: Able to work collaboratively in a team and also independently with minimal guidance, prioritizing tasks as needed.
• Project Management: Proven ability to manage multiple projects and meet deadlines effectively.

Preferred Experience:

• Regulatory Background: 3-5 years of experience in a regulated or pharmaceutical environment with a solid working knowledge of GMP and familiarity with aseptic processing.
• Leadership & Initiative: Demonstrated experience in driving improvements and successfully completing initiatives within a quality assurance role.

This role offers the chance to work within a dynamic environment, contributing to the continuous enhancement of the company's quality and regulatory standards.