About the Role
We're hiring a Quality Specialist to join a growing life sciences company based in Shannon. This is a hands-on quality role in a GMP-regulated environment supporting cold chain logistics, warehousing, and supply chain operations.
You'll focus on driving quality compliance, introducing SOPs, and managing change controls to support operations in the life sciences space.
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Key Responsibilities
* Write and implement SOPs across warehouse, logistics, and supply chain functions.
* Manage and coordinate change control processes aligned with GMP guidelines.
* Lead or support investigations into deviations, non-conformances, and customer complaints.
* Drive CAPA implementation and support root cause analysis.
* Monitor quality KPIs and trends, and support continuous improvement.
* Ensure compliance with GMP, GDP, and regulatory standards (HPRA, FDA, IAA.
* Liaise with internal teams to ensure quality is built into all aspects of operations.
* Support audits and inspections, maintaining a strong state of readiness.
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Key Requirements
* Degree in Science, Engineering, or a related field.
* 2–5 years' experience in a GMP-regulated environment (pharma, biopharma, logistics, or medtech).
* Experience creating and managing SOPs and change control processes.
* Understanding of cold chain, warehousing, and supply chain quality requirements.
* Strong knowledge of QMS processes, CAPA, and deviation management.
* Strong attention to detail with a proactive and collaborative approach. Transport Responsibilities
* Oversee compliance for air, sea, and road transport of life sciences products, ensuring adherence to GDP, GMP, and IATA standards.
* Ensure operations meet Regulated Agent (RA) requirements, including staff training, documentation, and security processes for secure supply chains.
* Implement and maintain procedures for secure cargo handling, ensuring shipments meet aviation security and regulatory obligations under EU and national aviation security legislation.
* Support compliance with aviation security requirements, including:
* Background checks, vetting, and training of staff involved in secure cargo operations.
* Control and monitoring of access to secure areas and cargo storage facilities.
* Maintenance of secure supply chain integrity, including chain of custody documentation and tamper-evident sealing.
* Partner with carriers, freight forwarders, and logistics providers to ensure temperature-controlled and secure transportation is consistently maintained.
* Audit and monitor transport partners to confirm compliance with secure cargo and RA programs, including cargo screening, chain of custody, and documentation requirements.
* Support investigations and CAPAs related to transport deviations (e.g., temperature excursions, security breaches, or regulatory non-compliance).
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Desirable
* Exposure to quality in a 3PL, warehouse, or temperature-controlled logistics setting.
* Familiarity with ISO 13485, GDP, and QMS platforms like TrackWise or Vee
Job Types: Full-time, Permanent
Pay: €55,000.00-€65,000.00 per year
Benefits:
* Additional leave
* Company pension
* Employee assistance program
* On-site parking
* Private medical insurance
* Sick pay
Work Location: In person