Global Quality Operations Technician – QA & Compliance

pciservices; Stamullen; On-site; EUR 30,000 - 42,000; Full time

Job summary

PCI Pharma Services in Stamullen, Co Meath invites a Quality Technician to join our manufacturing support team. You will generate packaging instructions, review batch records, and ensure cGMP compliance while maintaining rigorous documentation and traceability.

The role emphasizes attention to detail, adherence to QA procedures, and collaboration with production to release materials and prevent deviations. A degree and relevant experience are preferred for progression within our quality network.

Qualifications

• Degree or relevant experience required.
• Experience with QA documentation and record keeping preferred.
• Understanding of cGMP guidelines is advantageous.

Responsibilities

• Generate Packaging Instructions, Batch Packaging Records and labels for production from Master documents.
• Perform AQLs as required during production operations.
• Sampling, approval and release of incoming goods, packaging materials and product for use in production.
• Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers and review them.
• Review and filing of stock cards, approval forms, equipment LUMAC logs and other production logbooks.
• Identify training needs with production manager and conduct staff training as required.
• Assist with environmental monitoring procedures and update spreadsheets for trending results.
• Ad-hoc checks, in-process checks and documentation review on production lines.
• Approval of Line clearance procedures.
• Approval of Pre-production samples.
• Maintain batch documents and retain samples in archive; update PQR database after QP release.
• Liaise with Customers / suppliers for artwork-related queries and manage artwork approvals.
• Raise Deviations, Corrective Action Requests, Non-Conformance reports as required and communicate issues to QC Manager.
• Ensure activities comply with cGMP requirements and assist in validation studies.
• Support safe work practices and report defects to Safety Officer; attend Health & Safety meetings.

Skills

Quality control

Documentation

Attention to detail

Education

Degree in a relevant field

Job description

PCI Pharma Services in Stamullen, Co Meath invites a Quality Technician to join our manufacturing support team. You will generate packaging instructions, review batch records, and ensure cGMP compliance while maintaining rigorous documentation and traceability.

The role emphasizes attention to detail, adherence to QA procedures, and collaboration with production to release materials and prevent deviations. A degree and relevant experience are preferred for progression within our quality network.