Quality Systems Specialist — cGMP, Audits & Process Excellence

PCI Pharma Services; Leinster; On-site; EUR 48,000 - 72,000; Full time

Job summary

PCI Pharma Services is seeking a Quality Assurance professional to implement and execute day-to-day QA tasks within the City North business unit. The role focuses on QA matters around processes and documentation.

The position involves writing/reviewing SOPs, deviations, CAPAs and reports, conducting internal and external audits, and supporting customer/regulatory audits. It offers exposure to cross‑functional teams in a growing biopharma network.

Responsibilities

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
• Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
• Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
• Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
• Prepare Quarterly reports for each site.
• Prepare Product Quality Review reports.
• Prepare & present Monthly/Annual Metrics.
• Complete complaints investigations and assist with close out of complaints.
• Perform cGMP internal audits.
• Assist in the performance of external audits (as required).
• Responsible for executing training for quality & other relevant persons.
• Assist with preparation for customer/regulatory audits.
• Assist with audit requests during customer/regulatory audits.
• Prepare responses to customer audits.
• Host/attend cross departmental meetings as required as quality representation.
• Identify and support opportunities for improving processes and or procedures.
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

Job description

PCI Pharma Services is seeking a Quality Assurance professional to implement and execute day-to-day QA tasks within the City North business unit. The role focuses on QA matters around processes and documentation.

The position involves writing/reviewing SOPs, deviations, CAPAs and reports, conducting internal and external audits, and supporting customer/regulatory audits. It offers exposure to cross‑functional teams in a growing biopharma network.