QA Specialist
- Cork
- Permanent
- Full-time
We are seeking a QA Specialist for a contract role within the Quality Assurance (QA) Department, specifically in the Quality Monitoring team. The successful candidate will support key quality activities including Annual Product Quality Reviews, Customer Complaint Investigations, Counterfeit Sample Assessments, QA Documentation Review & Approval, and Quality Metrics Reporting.This role requires a solid understanding of quality assurance systems, current Good Manufacturing Practices (cGMPs), and standard QA procedures. The ideal candidate is proactive, detail-oriented, and able to exercise sound judgment within established protocols and guidelines.Key Responsibilities:Participate in inter-departmental and cross-functional teams.Author site contributions to Annual Product Quality Reviews and coordinate with global teams.Conduct counterfeit assessments related to product complaints.Investigate customer complaints in a timely and thorough manner.Collect and report on quality metrics.Contribute to the authoring, reviewing, and approval of Standard Operating Procedures (SOPs) and other controlled documents.Conduct QA walkthroughs to ensure site compliance with GMP requirements.Work on routine assignments, recognizing deviations from standard practices.Apply judgment within defined procedures to determine appropriate courses of action.Operate independently on routine work, with general guidance for new assignments.Qualifications and Experience:Minimum of 2 years of relevant experience in a GMP-regulated environment.Bachelor’s degree in a scientific or related field.Previous experience in the pharmaceutical industry, ideally within a QA function, is preferred.Strong working knowledge of cGMPs and quality systems (FDA / EMA standards).Familiarity with OPEX Lean tools and root cause analysis methodologies.Demonstrated skill in audits, investigations, and technical report writing.Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint).Excellent communication skills, both written and verbal.Preferred Personal Attributes:Positive and proactive mindset.Resilient and adaptable in dynamic environments.Ability to engage with multiple stakeholders to meet objectives.Curious, with a strong desire to learn and improve.Demonstrates operational excellence and a systematic approach to prioritization.Process-oriented with a focus on achieving high-quality outcomes.Core Values Expected:Integrity – Always doing the right thingTeamwork – Collaborating effectively and in good faithExcellence – Committed to high performance and quality standardsAccountability – Taking ownership of responsibilities and outcomesInclusion – Embracing diversity and fostering a collaborative environment