QA Warehouse Specialist: cGMP & Biopharma Impact

PCI TRGR Penn Pharmaceutical Services Ltd; Dundalk; On-site; EUR 32,000 - 42,000; Full time

Job summary

PCI Pharma Services in Dundalk, Ireland, is seeking a QA/Quality Assurance professional to support sampling, release, and documentation for incoming goods and materials used in production.

Responsibilities include reviewing CoA/CoC, maintaining sampling records, managing SCDs, and liaising on artwork approvals while ensuring cGMP compliance and continual improvement through CAPAs and deviations handling.

Qualifications

• Degree in life sciences or a related field.
• Experience with CGMP and QA documentation.
• Familiarity with CoA/CoC review and deviation handling.

Responsibilities

• Sample, approve, and release incoming goods, packaging materials, and products for use in production.
• Review and file Certificates of Analysis (CoA) / Certificates of Conformance (CoC).
• Maintain sampling documentation and archive retain samples.
• Manage the Supplier/Customer Defect (SCD) system and issue SCD numbers.
• Liaise with customers and suppliers on artwork-related queries and approve artwork.
• Review and approve Master Packaging Material Specifications.
• Raise, investigate, and close deviations and CAPAs.
• Assist in validation studies and ensure safe work practices.

Skills

cGMP compliance

Documentation

Quality systems

Training

CAPA

Deviations handling

SCD process

Education

Bachelor's degree in Life Sciences

Tools

QMS software

CoA/CoC review

MS Excel

Job description

PCI Pharma Services in Dundalk, Ireland, is seeking a QA/Quality Assurance professional to support sampling, release, and documentation for incoming goods and materials used in production.

Responsibilities include reviewing CoA/CoC, maintaining sampling records, managing SCDs, and liaising on artwork approvals while ensuring cGMP compliance and continual improvement through CAPAs and deviations handling.