GMP QA Warehouse Specialist

PCI Pharma Services; Stamullen; On-site; EUR 38,000 - 58,000; Full time

Job summary

PCI Pharma Services seeks a Quality Assurance professional to support GMP-compliant operations across Stamullen, Dundalk and other sites. This full-time role covers sampling, QA review, document control and deviation management within a fast-paced biopharma environment.

You will collaborate with suppliers and customers, ensure cGMP adherence, and contribute to training, audits and continuous improvement as part of PCI's commitment to life-changing therapies.

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 work toward clearly defined goals, communicate progress effectively, and meet predefined targets
• One to two years of experience working in Quality / QA
• Ability to manage multiple tasks and prioritize effectively based on business needs
• Strong problem-solving and troubleshooting skills, with a dynamic and proactive approach
• Self-motivated with a results-driven mindset

Responsibilities

• Sampling, approval and release incoming goods for use in production.
• Request Certificates of Analysis / Conformance for materials and product.
• 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 and close out.
• Liaise with customers/suppliers for artwork queries and approvals.
• Review and approval of Master Packaging Material Specifications.
• Ensure housekeeping and conduct audits with reports.
• Raise and close deviations and CAPAs as required.
• Ensure activities follow cGMP requirements.
• Assist in validation studies as required.
• Ensure safe work practices and attend Health & Safety meetings.
• Carry out additional tasks to support company goals.
• Scan documents into designated folder and update the Archive list.

Skills

GMP experience

Regulated environment

Problem-solving

Multitasking

Communication

Education

Bachelor’s or associate degree or Diploma / Certificate in GMP Regulatory and Compliance or similar

Job description

PCI Pharma Services seeks a Quality Assurance professional to support GMP-compliant operations across Stamullen, Dundalk and other sites. This full-time role covers sampling, QA review, document control and deviation management within a fast-paced biopharma environment.

You will collaborate with suppliers and customers, ensure cGMP adherence, and contribute to training, audits and continuous improvement as part of PCI's commitment to life-changing therapies.