- Posted 03 April 2025
- LocationIreland
- 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:
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Develop and implement QC systems, sampling plans, and testing strategies.
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Collaborate with internal/external teams to ensure GMP/GLP compliance.
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Review and execute documentation (SOPs, CoAs, test methods, reports, investigations).
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Investigate out-of-spec/limit results and lead CAPA implementation.
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Support analytical training programs and drive continuous improvement initiatives.
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Manage lab systems (e.g., LIMS, LabX, UV software) and maintain good housekeeping practices (6S).
Top Skills & Qualifications:
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2+ years' QC experience in a GMP pharmaceutical environment.
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Scientific degree required; postgraduate qualification a plus.
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Proficiency in QC documentation and lab investigations.
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Strong knowledge of analytical systems and quality standards.
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Excellent problem-solving, organisation, and cross-functional communication skills.
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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.