Quality Operations Technician Dundalk

PCI TRGR Penn Pharmaceutical Services Ltd; Leinster; On-site; EUR 36,000 - 48,000; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd is seeking a Quality Operations Technician for our Dundalk team (Thu-Sat night shift). You will sample, release, and review incoming goods, packaging materials, and products for production, while maintaining documentation and coordinating with suppliers on deviations and CAPAs.

You will ensure cGMP compliance, support validation studies, and uphold safety practices while liaising on artwork approvals and Master Packaging Material Specifications.

Qualifications

• Role in pharma quality operations requires accurate sampling and documentation.
• Experience in reviewing Certificates of Analysis (CoA) and Certificates of Conformance (CoC).
• Familiarity with cGMP requirements and validation activities.
• Strong housekeeping and SH&E awareness; ability to raise and close deviations and CAPAs.

Responsibilities

• Sample, approve, and release incoming goods, packaging materials, and products for use in production.
• Request and review CoA/CoC for incoming materials and products.
• Maintain sampling records and archive retain samples.
• Manage SCD system including issuing numbers and closure with suppliers/customers.
• Liaise on artwork-related queries and approvals, review Master Packaging Material Specifications.
• Ensure compliance with cGMP and participate in validation studies as required.
• Uphold safe work practices and attend Health and Safety meetings.

Job description

## Quality Operations Technician DundalkApply: Dundalk, Co. Louth, IRL: Full time: Posted Today: JR119888Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.**We are PCI.**Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. We are looking for a Quality Operations technician to join our Dundalk Team (Thursday - Saturday night shift) **Summary of Role** * Sample, approve, and release incoming goods, packaging materials, and products (where required) for use in production* Request and review Certificates of Analysis (CoA) / Certificates of Conformance (CoC) for incoming goods, packaging materials, and products* Review and file acetates for use during sampling activities* Identify training needs and conduct staff training as required* Maintain sampling documentation and archive retain samples* Manage the Supplier/Customer Defect (SCD) system, including issuance of SCD numbers, coordination with customers and suppliers, and closure of SCDs* Liaise with customers and suppliers on artwork-related queries and manage artwork approvals* Review and approve Master Packaging Material Specifications* Ensure high standards of housekeeping; conduct housekeeping audits and prepare reports* Raise, investigate, and close deviations and Corrective and Preventive Actions (CAPA) as required* Ensure all activities are conducted in compliance with current Good Manufacturing Practice (cGMP) requirements* Assist in validation studies as required* Ensure safe work practices are followed at all times, report safety issues immediately to the Safety Officer, and attend Health and Safety meetings* Perform other duties as required from time to time in line with the overall goals of the company### **Key Responsibilities** * Ensure safe work practices are followed at all times and report any near misses immediately to the EHS Department.Carry out other duties as required from time to time in line with the overall goals of the company. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future