Quality Operations Technician — cGMP & Material Release

PCI Pharma Services; Stamullen; Remote; EUR 40,000 - 55,000; Full time

Job summary

PCI Pharma Services is seeking a Quality Operations Technician for the Dundalk team (Thu-Sat day shift) to support QA sampling, release of materials, and documentation in accordance with cGMP. The role involves reviewing CoA/CoC, managing SCDs, and coordinating with customers and suppliers on artwork and deviations.

You will ensure high housekeeping standards, assist in validation studies, and maintain training records for staff development.

Qualifications

• GxP aware and able to review certificates and specs.
• Experience with QA documentation and records handling preferred.
• Ability to identify training needs and conduct staff training as required.
• Strong commitment to maintaining housekeeping and safety standards.

Responsibilities

• Sample, approve, and release incoming goods, packaging materials, and products for use in production.
• Review COA/CoC for incoming materials and products; file and archive relevant documents.
• Maintain sampling documentation and retain samples; manage deviations and CAPA as needed.
• Manage the Supplier/Customer Defect (SCD) system with issue tracking and closure.
• Coordinate artwork approvals and respond to artwork-related queries.
• Ensure compliance with cGMP and participate in validation studies as required.

Skills

CoA review

CoC review

cGMP compliance

Documentation

Training staff

CAPA investigation

SCD system

Job description

PCI Pharma Services is seeking a Quality Operations Technician for the Dundalk team (Thu-Sat day shift) to support QA sampling, release of materials, and documentation in accordance with cGMP. The role involves reviewing CoA/CoC, managing SCDs, and coordinating with customers and suppliers on artwork and deviations.

You will ensure high housekeeping standards, assist in validation studies, and maintain training records for staff development.