GMP Quality Operations Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Blanchardstown; On-site; EUR 42,000 - 65,000; Full time

Job summary

PCI Pharma Services in Ireland is offering a temporary maternity cover role focused on raw materials and finished product release, QA oversight, and cGMP compliance. You will join a team dedicated to high quality, efficient operations in a fast-paced pharmaceutical environment.

The position involves approving incoming goods, reviewing CoA/CoC, managing SCDs, and supporting training, deviations, and CAPA activities while upholding rigorous housekeeping and safety standards.

Responsibilities

• Approve incoming goods, packaging materials, and products 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.

Job description

PCI Pharma Services in Ireland is offering a temporary maternity cover role focused on raw materials and finished product release, QA oversight, and cGMP compliance. You will join a team dedicated to high quality, efficient operations in a fast-paced pharmaceutical environment.

The position involves approving incoming goods, reviewing CoA/CoC, managing SCDs, and supporting training, deviations, and CAPA activities while upholding rigorous housekeeping and safety standards.