Quality Systems Specialist — cGMP & Audits

PCI Pharma Services; Drogheda; On-site; EUR 42,000 - 64,000; Full time

Job summary

PCI Pharma Services in Ireland seeks a Quality Assurance professional to implement day-to-day QA tasks within the City North site. You will own documentation, ensure cGMP compliance, and support internal and external audits.

The role focuses on writing/reviewing SOPs and reports, managing deviations, CAPAs, NCRs, and metrics, while coordinating with cross-functional teams to improve processes and ensure timely audit responses.

Responsibilities

• Ensure safe work practices and report near misses to EHS.
• Write and review SOPs, Work Instructions, BPRs and Forms.
• Write and review Deviations, NCRs, CAPAs and prepare final reports for QP review.
• Follow up on change control actions and drive on-time closure.
• Prepare quarterly site reports and Product Quality Review reports.
• Prepare and present Monthly/Annual Metrics.
• Complete complaints investigations and assist with close-out of complaints.
• Perform cGMP internal audits and assist external audits as required.
• Execute training for quality and other relevant personnel.
• Assist with customer/regulatory audits preparation and responses.
• Host cross-department meetings as quality representation.
• Identify opportunities to improve processes and procedures.
• Handle ad hoc projects to meet department and business needs.

Job description

PCI Pharma Services in Ireland seeks a Quality Assurance professional to implement day-to-day QA tasks within the City North site. You will own documentation, ensure cGMP compliance, and support internal and external audits.

The role focuses on writing/reviewing SOPs and reports, managing deviations, CAPAs, NCRs, and metrics, while coordinating with cross-functional teams to improve processes and ensure timely audit responses.