GMP QA Warehouse Specialist

PCI Pharma Services; Blanchardstown; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

PCI Pharma Services in Ireland seeks a Quality/Regulatory Assurance professional to support GMP-compliant operations across incoming goods and materials, documentation, and deviation management. You will ensure cGMP adherence, coordinate with suppliers and customers, and contribute to training and process improvements.

The role emphasizes attention to detail, timely training, and rigorous documentation, with opportunities to impact product quality and patient outcomes in a global biopharma

Qualifikationen

• Bachelor’s or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
• 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

Aufgaben

• Sampling, approval and release incoming goods, packaging materials and product for use in production.
• Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product for use in production.
• Review and filing of acetates for use in sampling.
• Identify training needs and conduct staff training as required.
• Maintenance of sampling documentation and retain samples in archive.
• Management of the SCD system. Issue SCD numbers, coordinate completion with customers/suppliers and close out.
• Liase with customers/supplier for artwork queries and management of artwork approval.
• Review and approval of Master Packaging Material Specifications.
• Ensure excellence in housekeeping and carry out audits.
• Raise and close deviations and Corrective/Preventative actions as required.
• Ensure activities follow the requirements of cGMP.
• Assist in validation studies as required.
• Ensure safe work practices, report defects to Safety Officer and attend Health and Safety meetings.
• Credit to perform other tasks to support company goals.
• Scan documents into designated folder and update Archive list.

Kenntnisse

Attention to detail

Results-driven

Prioritization

Communication

Ausbildung

Bachelor’s or Associate degree in GMP/Regulatory/Compliance

Jobbeschreibung

PCI Pharma Services in Ireland seeks a Quality/Regulatory Assurance professional to support GMP-compliant operations across incoming goods and materials, documentation, and deviation management. You will ensure cGMP adherence, coordinate with suppliers and customers, and contribute to training and process improvements.

The role emphasizes attention to detail, timely training, and rigorous documentation, with opportunities to impact product quality and patient outcomes in a global biopharma