Quality Systems Specialist — Compliance & Audits

pciservices; Stamullen; On-site; EUR 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Ireland (City North) seeks a Quality Assurance professional to implement and execute day-to-day QA tasks focused on processes and documentation within the City North business unit.

The role includes leading deviations, CAPAs, audits, training and preparation of quality metrics, while collaborating with cross-functional teams to ensure compliance and continuous improvement.

Responsibilities

• Ensure safe work practices are followed; report near misses to EHS.
• Write and review SOPs, Work Instructions, BPRs and forms.
• Write and review Deviations, non-conformances, CAPAs; prepare reports for QP review.
• Follow up on change control actions and drive on-time closure.
• Prepare Quarterly site reports.
• Prepare Product Quality Review reports.
• Prepare & present Monthly/Annual Metrics.
• Conduct complaints investigations and assist close-out.
• Perform cGMP internal audits and assist external audits.
• Prepare training for quality personnel and others.
• Assist audits preparation for customer/regulatory audits.
• Prepare responses to customer audits.
• Lead cross-department meetings as quality representative.
• Identify opportunities to improve processes.
• Manage ad hoc projects as required.
• Carry out other tasks to meet company goals.

Job description

PCI Pharma Services in Ireland (City North) seeks a Quality Assurance professional to implement and execute day-to-day QA tasks focused on processes and documentation within the City North business unit.

The role includes leading deviations, CAPAs, audits, training and preparation of quality metrics, while collaborating with cross-functional teams to ensure compliance and continuous improvement.