Quality Assurance Pro: cGMP & Process Excellence

PCI Pharma Services; Blanchardstown; Hybrid; EUR 50,000 - 85,000; Full time

Job summary

PCI Pharma Services in Blanchardstown, Ireland, is seeking a Quality Assurance professional to implement and execute day-to-day QA tasks across processes and documentation in the City North business unit.

You will write and review SOPs, Deviations and CAPAs, lead audits, and prepare reports and metrics for regulatory and customer audits. A strong grasp of cGMP and QA systems, plus effective cross-functional collaboration, is essential.

Qualifications

• Quality Assurance experience in pharma manufacturing or similar regulated environment.
• Strong understanding of GMP/cGMP requirements and documentation controls.
• Proven ability to write, review and improve QA related documents.

Responsibilities

• Ensure safe work practices and report near misses to the EHS team.
• Write and review SOPs, Work Instructions, BPRs and Forms.
• Review Deviations, NCRs, CAPAs and prepare final QP review reports.
• Follow up on change controls and drive on-time closure of actions.
• Prepare site quarterly reports and Product Quality Review reports.
• Prepare and present monthly/annual metrics.
• Complete complaints investigations and assist with close out.
• Perform cGMP internal audits and assist with external audits.
• Execute QA training for quality personnel and others.
• Assist with customer/regulatory audits preparations and responses.
• Represent QA in cross-department meetings and identify process improvements.
• Lead ad hoc projects to meet department needs and goals.

Skills

Quality Assurance

GxP Knowledge

Job description

PCI Pharma Services in Blanchardstown, Ireland, is seeking a Quality Assurance professional to implement and execute day-to-day QA tasks across processes and documentation in the City North business unit.

You will write and review SOPs, Deviations and CAPAs, lead audits, and prepare reports and metrics for regulatory and customer audits. A strong grasp of cGMP and QA systems, plus effective cross-functional collaboration, is essential.