GMP-Driven Quality Systems Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Ireland; Remote; EUR 60,000 - 85,000; Full time

Job summary

PCI Pharma Services is seeking a Quality Systems Specialist to support day-to-day QA activities across multiple site locations in Ireland. You will be responsible for maintaining robust quality systems, writing and reviewing SOPs and forms, and ensuring timely action on deviations and CAPAs.

The role includes preparing product quality reviews and supporting internal/external audits. The role requires a strong background in cGMP, QA documentation, and cross-functional collaboration to drive

Qualifications

• Knowledge of quality systems, GMP/CGMP practices.
• Experience in writing and reviewing SOPs, work instructions and forms.
• Experience with deviations, non-conformances, CAPA and change control processes.
• Auditing experience, internal and external (customer/regulatory).

Responsibilities

• Implement and execute day-to-day Quality Assurance tasks.
• Manage QA matters around processes and documentation in the designated business unit.
• Write, review and ensure timely closure of deviations, NCRs and CAPAs.
• Coordinate audits and prepare responses for customer/regulatory audits.
• Provide QA training and participate in cross-department meetings.

Job description

PCI Pharma Services is seeking a Quality Systems Specialist to support day-to-day QA activities across multiple site locations in Ireland. You will be responsible for maintaining robust quality systems, writing and reviewing SOPs and forms, and ensuring timely action on deviations and CAPAs.

The role includes preparing product quality reviews and supporting internal/external audits. The role requires a strong background in cGMP, QA documentation, and cross-functional collaboration to drive