Overview
Quality Assurance Specialist Jobs in Dublin, County Dublin, Ireland at Force Recruitment
Title: Quality Assurance Specialist
Company: Force Recruitment
Location: Dublin, County Dublin, Ireland
Key Responsibilities
Quality System Management
Act as the QA SME for PQS systems, including deviations, change control, complaints, validation, and risk management.
Review and approve Standard Operating Procedures (SOPs) and other controlled documents.
Author and develop assigned QA SOPs and documentation.
Provide QA oversight for operational activities at approved service providers (QC testing, material storage, supply).
Lead or facilitate Quality Risk Management (QRM) activities in line with ICH Q9 rev1.
Identify and implement continuous quality system improvements.
Batch Documentation & Release Support
Provide guidance on master batch documentation development.
Review and approve executed batch documentation.
Assist QA leadership and Qualified Person (QP) teams in documentation preparation for release activities.
Supplier & Manufacturing Oversight
Provide QA oversight for on-site manufacturing, materials management, warehousing, and quality control testing.
Prepare and review Quality Agreements for service providers.
Conduct Supplier GxP Monitoring during onboarding and throughout the lifecycle.
Regulatory Compliance & Inspection Readiness
Execute assigned inspection readiness activities.
Participate in regulatory inspections, interact with inspectors, and contribute to responses and follow-ups.
Experience & Qualifications
Essential Requirements:
Minimum 3 years of experience in cGMP pharmaceutical operations with direct exposure to quality systems.
Degree in a scientific discipline or equivalent qualification.
Ability to work independently and flexibly while fostering a high-performance quality culture.
Preferred Experience (Advantageous):
Supplier Quality Management activities.
Quality Risk Management experience, particularly in leading or facilitating QRM activities.
Knowledge of Good Distribution Practice (GDP).
