Quality Operations Technician Dundalk

PCI Pharma Services; Leinster; On-site; EUR 32,000 - 45,000; Full time

Job summary

PCI Pharma Services in Dundalk is seeking a Quality Operations Technician for the Thursday–Saturday night shift to support cGMP compliant operations. You will sample, approve, and release incoming materials for production and ensure accurate documentation across quality systems.

The role involves reviewing CoA/CoC, maintaining sampling records, and managing defect tracking with suppliers and customers. Attention to detail and strict adherence to GMP are essential for success.

Qualifications

• Experience following cGMP requirements in a manufacturing or quality environment.
• Strong attention to detail and meticulous documentation practices.
• Ability to identify and report deviations and CAPAs in a timely manner.

Responsibilities

• Sample, approve, and release incoming goods, packaging materials, and products for production.
• Request and review CoA/CoC for incoming goods and materials.
• Maintain sampling documentation and archive retain samples.
• Manage the SCD system including issue numbers and closure with customers/suppliers.

Skills

Quality control

cGMP awareness

Documentation accuracy

Tools

SCD system

Job description

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).

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

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.