Quality Operations Technician - Night Shift

PCI TRGR Penn Pharmaceutical Services Ltd; Dundalk; In loco; EUR 38.000 - 54.000; Tempo pieno

Descrizione del lavoro

PCI Pharma Services in Dundalk is seeking a Quality Operations Technician for the Thursday–Saturday night shift. You will sample, review, and release materials, manage CoA/CoC documentation, and coordinate with suppliers to resolve deviations within a cGMP framework.

Responsibilities include maintaining sampling records, training staff, and ensuring compliance with regulatory standards. This role supports continuous improvement and safe, efficient manufacturing operations.

Competenze

• Experience in GMP/cGMP environments.
• Ability to review CoA/CoC for incoming materials.
• Experience with deviation investigations and CAPA processes.

Mansioni

• Sample, approve, and release incoming goods and packaging materials for production.
• Request and review CoA/CoC for incoming materials and products.
• Identify training needs and conduct staff training as required.
• Maintain sampling documentation and archive retain samples.
• Manage the SCD system with coordination with customers and suppliers, and close SCDs.
• Ensure all activities comply with cGMP requirements.

Conoscenze

Quality control

cGMP compliance

Documentation

Training

Deviation investigations

Strumenti

SCD system

CAPA system

Master Packaging Specs

Descrizione del lavoro

PCI Pharma Services in Dundalk is seeking a Quality Operations Technician for the Thursday–Saturday night shift. You will sample, review, and release materials, manage CoA/CoC documentation, and coordinate with suppliers to resolve deviations within a cGMP framework.

Responsibilities include maintaining sampling records, training staff, and ensuring compliance with regulatory standards. This role supports continuous improvement and safe, efficient manufacturing operations.