Quality Operations Technician Dundalk

PCI TRGR Penn Pharmaceutical Services Ltd; Dundalk; On-site; EUR 38,000 - 54,000; Full time

Job summary

PCI Pharma Services in Dundalk is seeking a Quality Operations Technician for the Thursday–Saturday night shift. You will sample, review, and release materials, manage CoA/CoC documentation, and coordinate with suppliers to resolve deviations within a cGMP framework.

Responsibilities include maintaining sampling records, training staff, and ensuring compliance with regulatory standards. This role supports continuous improvement and safe, efficient manufacturing operations.

Qualifications

• Experience in GMP/cGMP environments.
• Ability to review CoA/CoC for incoming materials.
• Experience with deviation investigations and CAPA processes.

Responsibilities

• Sample, approve, and release incoming goods and packaging materials for production.
• Request and review CoA/CoC for incoming materials and products.
• Identify training needs and conduct staff training as required.
• Maintain sampling documentation and archive retain samples.
• Manage the SCD system with coordination with customers and suppliers, and close SCDs.
• Ensure all activities comply with cGMP requirements.

Skills

Quality control

cGMP compliance

Documentation

Training

Deviation investigations

Tools

SCD system

CAPA system

Master Packaging Specs

Job description

Summary of Role

Life 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)

• 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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.