Quality Operations Technician - Impactful Biopharma QC

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; On-site; EUR 32,000 - 48,000; Full time

Job summary

PCI Pharma Services is seeking a Quality Technician to join our Stamullen Team in Ireland. You will generate packaging instructions and records for production from master documents, perform AQLs, and ensure proper sampling and release of incoming goods and materials.

You will review batch documents, manage artwork-related queries, raise deviations and CAPAs, and support training and environmental monitoring while maintaining cGMP standards. Essential degree or relevant experience required.

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 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.
• Review and filing of certificates and batch documentation.
• Review and filing of stock cards, approval forms, equipment logs and other production logbooks.
• Identify training needs with the production manager and conduct staff training as required.
• Assist with environmental monitoring procedures and trend results.
• Ad-hoc checks and in-process checks on production lines.
• Approval of Line clearance procedures.
• Approval of Pre-production samples.
• Maintenance of batch documents and archive samples.
• Update PQR database after QP release.
• Liaise with customers/suppliers for artwork-related queries and approvals.
• Raise Deviations, CAPAs and NCRs and communicate issues to QC Manager.
• Ensure activities comply with cGMP requirements.
• Assist in performing validation studies.
• Follow safe work practices and report safety concerns.
• Carry out additional tasks to support company goals.

Job description

PCI Pharma Services is seeking a Quality Technician to join our Stamullen Team in Ireland. You will generate packaging instructions and records for production from master documents, perform AQLs, and ensure proper sampling and release of incoming goods and materials.

You will review batch documents, manage artwork-related queries, raise deviations and CAPAs, and support training and environmental monitoring while maintaining cGMP standards. Essential degree or relevant experience required.