Quality Assurance Specialist – cGMP & Audits

PCI Pharma Services; Dundalk (MD); On-site; USD 46,000 - 75,000; Full time

Job summary

PCI Pharma Services in Dundalk, Ireland, is seeking a full-time Quality Assurance professional to manage day-to-day QA activities within the City North unit. You will write and review SOPs, handle deviations, CAPAs, complaints, and QC documents, and support internal and external audits to ensure cGMP compliance.

Join a team focused on delivering high-quality therapies while fostering continuous improvement, training, and effective cross-functional collaboration across sites and regulatory bodies.

Qualifications

• Experience in pharmaceutical Quality Assurance.
• Knowledge of cGMP and regulatory requirements.
• Ability to write and review SOPs and QA documentation.

Responsibilities

• Write and review SOPs, Work Instructions, BPRs and forms.
• Write and review Deviations, Non-Conformance reports, Corrective Action Requests and prepare final reports for QP review.
• Support change control actions and drive on-time closure.
• Prepare quarterly reports for each site.
• Prepare Product Quality Review reports.
• Prepare & present monthly/annual metrics.
• Participate in cGMP internal audits and assist with external audits.
• Deliver QA training to relevant personnel.
• Assist with customer/regulatory audits and audit responses.
• Identify opportunities to improve processes and procedures.
• Lead ad hoc QA projects.

Job description

PCI Pharma Services in Dundalk, Ireland, is seeking a full-time Quality Assurance professional to manage day-to-day QA activities within the City North unit. You will write and review SOPs, handle deviations, CAPAs, complaints, and QC documents, and support internal and external audits to ensure cGMP compliance.

Join a team focused on delivering high-quality therapies while fostering continuous improvement, training, and effective cross-functional collaboration across sites and regulatory bodies.