QA Warehouse Specialist- Dundalk

PCI TRGR Penn Pharmaceutical Services Ltd; Dundalk; On-site; EUR 32,000 - 42,000; Full time

Job summary

PCI Pharma Services in Dundalk, Ireland, is seeking a QA/Quality Assurance professional to support sampling, release, and documentation for incoming goods and materials used in production.

Responsibilities include reviewing CoA/CoC, maintaining sampling records, managing SCDs, and liaising on artwork approvals while ensuring cGMP compliance and continual improvement through CAPAs and deviations handling.

Qualifications

• Degree in life sciences or a related field.
• Experience with CGMP and QA documentation.
• Familiarity with CoA/CoC review and deviation handling.

Responsibilities

• Sample, approve, and release incoming goods, packaging materials, and products for use in production.
• Review and file Certificates of Analysis (CoA) / Certificates of Conformance (CoC).
• Maintain sampling documentation and archive retain samples.
• Manage the Supplier/Customer Defect (SCD) system and issue SCD numbers.
• Liaise with customers and suppliers on artwork-related queries and approve artwork.
• Review and approve Master Packaging Material Specifications.
• Raise, investigate, and close deviations and CAPAs.
• Assist in validation studies and ensure safe work practices.

Skills

cGMP compliance

Documentation

Quality systems

Training

CAPA

Deviations handling

SCD process

Education

Bachelor's degree in Life Sciences

Tools

QMS software

CoA/CoC review

MS Excel

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. 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.

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.