QA Warehouse Specialist- Dundalk

pciservices; Leinster; On-site; EUR 42,000 - 66,000; Full time

Job summary

PCI Pharma Services is seeking personnel to support quality assurance and GMP-compliant operations in Ireland. The role involves sampling, releasing materials, and maintaining documentation to ensure production readiness.

Responsibilities include reviewing CoA/CoC, managing deviations and CAPA, and collaborating with suppliers and customers on artwork and specifications, all while upholding high housekeeping and safety standards.

Responsibilities

• Sample, approve, and release incoming goods, packaging materials, and products for production
• Review Certificates of Analysis (CoA) and Certificates of Conformance (CoC) for incoming materials
• Review and file acetates for sampling activities
• Identify training needs and conduct staff training
• Maintain sampling documentation and archive retain samples
• Manage the Supplier/Customer Defect (SCD) system and coordinate with customers and suppliers
• Liaise with customers and suppliers on artwork-related queries and manage artwork approvals
• Review and approve Master Packaging Material Specifications
• Ensure housekeeping standards and conduct housekeeping audits
• Raise, investigate, and close deviations and CAPA as required
• Ensure activities comply with cGMP; assist in validation studies
• Promote safe work practices and participate in Health and Safety meetings
• Perform other duties as required
• Carry out other duties as required from time to time in line with company goals

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.