- Posted 03 April 2025
- LocationDublin
- Job type Permanent
- Reference1826
QC Specialist
Job description
Job Title: Quality Control (QC) Specialist – GMP Manufacturing (ATMPs & Vaccines)
Location: Dublin 18
Industry: Advanced Therapeutics & Vaccines | Experience: 2+ years in GMP QC
About the Company:
Our client is a pioneering Irish-owned company transforming pharmaceutical manufacturing through advanced research in APC and digital-led processes. Their facility—dedicated to GMP clinical manufacturing—offers a seamless transition from process development to full-scale GMP manufacturing, focusing on Advanced Therapeutic Medicinal Products (ATMPs) and vaccines.
Role Overview:
This is a unique opportunity to help shape QC operations in a next-generation manufacturing site. You'll be instrumental in establishing QC systems, managing outsourced testing, and supporting regulatory compliance across vaccine and ATMP production.
Key Responsibilities:
Develop and implement QC systems, sampling plans, and testing strategies.
Collaborate with internal/external teams to ensure GMP/GLP compliance.
Review and execute documentation (SOPs, CoAs, test methods, reports, investigations).
Investigate out-of-spec/limit results and lead CAPA implementation.
Support analytical training programs and drive continuous improvement initiatives.
Manage lab systems (e.g., LIMS, LabX, UV software) and maintain good housekeeping practices (6S).
Top Skills & Qualifications:
2+ years' QC experience in a GMP pharmaceutical environment.
Scientific degree required; postgraduate qualification a plus.
Proficiency in QC documentation and lab investigations.
Strong knowledge of analytical systems and quality standards.
Excellent problem-solving, organisation, and cross-functional communication skills.
Ability to work independently and in a team-focused environment.
Why Join?
Be part of a revolutionary company driving local supply chain solutions for life-saving medicines. This is a high-growth opportunity to develop technically and professionally within a state-of-the-art facility on a collaborative campus shared with APC.