Quality Operations Technician — Global Impact

PCI Pharma Services; Leinster; On-site; EUR 35,000 - 48,000; Full time

Job summary

PCI Pharma Services in Dundalk seeks a Quality Technician for night shifts (Mon-Wed). You will generate packaging instructions, records and labels, perform AQLs, and manage release of materials for production. Ensure cGMP compliance and maintain QA documentation throughout production lines.

You will liaise with customers and suppliers on artwork approvals, raise deviations and CAPAs, and assist with validation studies, training, and environmental monitoring as needed.

Qualifications

• Degree and/or relevant experience is essential.

Responsibilities

• Generate Packaging Instructions, Batch Packaging Records and labels for use in production from Master documents.
• Perform AQLs as required during production operations.
• Sampling, approval and release incoming goods, packaging materials and product (where required) for use in production.
• Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers. Review and filing of same.
• Review and filing of stock cards, approval forms, equipment LUMAC logs and other production logbooks.
• Identify training needs in conjunction with the production manager and conduct staff training as required.
• Assist with environmental monitoring procedures, update spreadsheets to facilitate trending of results.
• Ad-hoc checks, in-process checks and documentation review on a routine basis on production lines.
• Approval of Line clearance procedures.
• Approval of Pre-production samples.
• Maintenance of batch documents and retain samples in archive. Update the PQR database after QP release.
• To liaise with Customers / suppliers for artwork related queries and management of approval of artwork.
• Raise Deviations, Corrective Action Requests, Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QC Manager/designee.
• Ensure activities observed are in compliance with the requirements of cGMP.
• Assist in performing validation studies.
• Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

Skills

Quality control

cGMP

Documentation

QA

Education

Degree

Job description

PCI Pharma Services in Dundalk seeks a Quality Technician for night shifts (Mon-Wed). You will generate packaging instructions, records and labels, perform AQLs, and manage release of materials for production. Ensure cGMP compliance and maintain QA documentation throughout production lines.

You will liaise with customers and suppliers on artwork approvals, raise deviations and CAPAs, and assist with validation studies, training, and environmental monitoring as needed.