Quality Operations Technician Dundalk

PCI Pharma Services; Dundalk; Remote; EUR 42,000 - 56,000; Full time

Job summary

PCI Pharma Services in Dundalk invites applications for a Quality Operations Technician. The role supports incoming goods inspection, CoA/CoC review, deviations, CAPA, and cGMP-compliant activities on a Thursday-Saturday day shift.

You will maintain sampling documentation, manage the SCD system with suppliers and customers, and participate in training, housekeeping audits, and safety meetings to ensure high quality standards at all times.

Qualifications

• Experience in pharmaceutical quality operations.
• Knowledge of CoA/CoC review is helpful.
• Familiarity with cGMP and quality systems.

Responsibilities

• Sample, approve, and release incoming goods and packaging.
• Review CoA/CoC for incoming materials and products.
• Raise deviations and CAPAs as required.
• Ensure compliance with cGMP and conduct housekeeping audits.
• Assist in training and safety meetings.

Skills

Attention to detail

Documentation

cGMP knowledge

Team collaboration

Tools

SCD system

Job description

Quality Operations Technician Dundalk# PCI Pharma Services Careers## Quality Operations Technician DundalkApply: Dundalk, Co. Louth, IRL: Full time: Posted Today: JR119890Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.**We are PCI.**Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.We are looking for a Quality Operations technician to join our Dundalk Team (Thursday - Saturday day shift) **Summary of Role** * Sample, approve, and release incoming goods, packaging materials, and products (where required) for use in production* Request and review Certificates of Analysis (CoA) / Certificates of Conformance (CoC) for incoming goods, packaging materials, and products* Review and file acetates for use during sampling activities* Identify training needs and conduct staff training as required* Maintain sampling documentation and archive retain samples* Manage the Supplier/Customer Defect (SCD) system, including issuance of SCD numbers, coordination with customers and suppliers, and closure of SCDs* Liaise with customers and suppliers on artwork-related queries and manage artwork approvals* Review and approve Master Packaging Material Specifications* Ensure high standards of housekeeping; conduct housekeeping audits and prepare reports* Raise, investigate, and close deviations and Corrective and Preventive Actions (CAPA) as required* Ensure all activities are conducted in compliance with current Good Manufacturing Practice (cGMP) requirements* Assist in validation studies as required* Ensure safe work practices are followed at all times, report safety issues immediately to the Safety Officer, and attend Health and Safety meetings* Perform other duties as required from time to time in line with the overall goals of the company### **Key Responsibilities** * Ensure safe work practices are followed at all times and report any near misses immediately to the EHS Department.Carry out other duties as required from time to time in line with the overall goals of the company. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future