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.
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