Quality Assurance Systems Lead — cGMP & Audits

PCI Pharma Services; Stamullen; On-site; EUR 55,000 - 75,000; Full time

Job summary

PCI Pharma Services in Ireland seeks a Quality Assurance professional to implement and execute day-to-day QA tasks within the City North site, focusing on QA matters around processes and documentation. The role involves writing and reviewing SOPs, deviations, CAPAs and managing related reports.

You will lead change controls, audits (internal and external), training, and preparation of QA metrics, Product Quality Review and regulatory responses, while driving continuous improvement and

Qualifications

• Experience with QA processes and document control in pharma.
• Knowledge of cGMP standards and regulatory expectations.
• Ability to write, review and approve QA documentation.

Responsibilities

• Ensure safe work practices and report near misses to EHS.
• Write and review SOPs, work instructions, BPRs and forms.
• Review deviations, non-conformance reports, CAPAs and final QP reports.
• Follow up on change controls and drive timely closure of actions.
• Prepare quarterly site reports and Product Quality Review summaries.
• Prepare and present monthly/annual metrics.
• Execute CGMP internal audits and assist external audits.
• Provide training for quality and other relevant personnel.
• Assist with customer/regulatory audits and responses.
• Lead cross-departmental quality meetings and identify process improvements.
• Participate in ad hoc projects to meet department goals.

Skills

Quality Assurance

cGMP

Documentation

Job description

PCI Pharma Services in Ireland seeks a Quality Assurance professional to implement and execute day-to-day QA tasks within the City North site, focusing on QA matters around processes and documentation. The role involves writing and reviewing SOPs, deviations, CAPAs and managing related reports.

You will lead change controls, audits (internal and external), training, and preparation of QA metrics, Product Quality Review and regulatory responses, while driving continuous improvement and