QA Officer - Shift

About Eirgen Pharma

Since 2005, Eirgen Pharma has been a dynamic pharmaceutical company based in Waterford, employing over 180 staff. The organization combines the flexibility of a smaller company with global ambitions to deliver superior medicines, fostering a collaborative and people-focused workplace culture.

Role Overview

The QA Officer on shift will oversee quality assurance activities related to manufacturing and packaging processes during their assigned work periods. The main goal is to ensure compliance with Good Manufacturing Practices (GMP), company quality benchmarks, approved procedures, and regulatory standards. This position includes monitoring production, performing line clearances and inspections, reviewing batch documentation, escalating quality concerns, and supporting the release of top-quality products. The role involves close teamwork with departments such as Manufacturing, Packaging, Quality Control, Engineering, and Warehouse, encouraging a culture that prioritizes quality, compliance, and ongoing improvement while safeguarding product safety.

Shift Schedule

The work pattern alternates weekly: one week from 6:00 AM to 2:00 PM, Monday through Friday, and the following week from 2:00 PM to 10:00 PM, Monday through Friday.

Key Responsibilities

• Deliver quality assurance oversight during manufacturing and packaging operations throughout assigned shifts.
• Ensure all production activities adhere to GMP standards, SOPs, approved batch records, and regulatory guidelines.
• Conduct line clearance inspections, in-process quality checks, and routine GMP audits to maintain product quality and manufacturing compliance.
• Examine batch documentation, equipment conditions, cleaning logs, and environmental parameters to facilitate timely product release.
• Detect, investigate, and escalate quality deviations, non-conformities, and compliance issues; assist in root cause analysis and corrective action/preventive action (CAPA) processes.
• Provide immediate quality assurance advice and support to production teams and foster continuous quality and compliance improvements.
• Assist with validation activities, change controls, internal and external audits, and regulatory inspections as needed.
• Maintain accuracy and completeness of QA records, ensure proper shift handovers, and comply with health, safety, environmental, and quality policies.

Candidate Profile

• Possess at least a degree in a science-related field.
• Preferred training in Good Manufacturing Practices (GMP) and Quality Management Systems.
• Bring a minimum of 2 to 3 years of experience in quality assurance within a GMP-regulated manufacturing setting.
• Experience supporting QA functions in both manufacturing and packaging environments.
• Skilled in conducting line clearances, in-process inspections, and reviewing batch documentation.
• Familiarity with deviation management, investigations, CAPA processes, change control, and risk assessment.
• Experience with participation in internal, customer, or regulatory audits is advantageous.

Why Work at Eirgen Pharma?

• Be part of a collaborative quality team operating in a fast-paced GMP environment.
• Access excellent benefits including pension schemes, health insurance, social club activities, and onsite canteen facilities.