GMP QA & Compliance Specialist (Warehouse)

PCI Pharma Services; Dundalk; On-site; EUR 45,000 - 55,000; Full time

Job summary

PCI Pharma Services in Dundalk, Ireland, is seeking a quality/QA professional with 2+ years in GMP or regulated environments. The role focuses on sampling, qualification, and documentation to ensure cGMP adherence.

You will manage SCD processes, artwork approvals, and Master Packaging Material Specifications while maintaining strict housekeeping and training. Strong problem-solving and multitasking skills are essential for success.

Qualifications

• Bachelor’s or associate degree or Diploma/Certificate in GMP, Regulatory and Compliance or similar.
• 2+ years’ experience working in GMP or Regulated Environment.
• Proven track record of delivering results.
• Ability to manage multiple tasks and prioritize effectively based on business needs.
• One to two years of experience working in Quality / QA.
• Strong problem-solving and troubleshooting skills.
• Self-motivated with a results-driven mindset.

Responsibilities

• Sampling, approval and release incoming goods for use in production.
• Request Certificates of Analysis / Conformance for incoming goods and packaging materials.
• Review and filing of acetates for sampling.
• Identify training needs and conduct staff training as required.
• Maintenance of sampling documentation and archive samples.
• Management of the Supplier/Customer Defect (SCD) system; issue numbers and close out.
• Liaise with customers/suppliers for artwork queries and approval of artwork.
• Review and approve Master Packaging Material Specifications.
• Maintain housekeeping; carry out audits and report findings.
• Raise/close deviations and CAPAs; ensure adherence to cGMP.
• Assist in validation studies as required.
• Ensure safe work practices; report health/safety issues.
• Scan documents into the designated folder and update Archive list.

Skills

Proven track record of delivering

Goal setting & progress communication

Strong problem-solving skills

Self-motivated & results-driven

Education

Bachelor’s/Associate degree in GMP/Regulatory

Diploma/Certificate in GMP/Regulatory

Job description

PCI Pharma Services in Dundalk, Ireland, is seeking a quality/QA professional with 2+ years in GMP or regulated environments. The role focuses on sampling, qualification, and documentation to ensure cGMP adherence.

You will manage SCD processes, artwork approvals, and Master Packaging Material Specifications while maintaining strict housekeeping and training. Strong problem-solving and multitasking skills are essential for success.