QA Specialist

Job Summary

CareerWise Recruitment is seeking a Quality Specialist for a 12-month contract with a pharmaceutical client based in Waterford, Ireland. The role requires working three days onsite and two days remotely. Ideal candidates will possess experience in quality assurance within a GMP environment, focusing on procedural compliance, batch documentation, maintaining quality systems, and delivering training related to these quality systems.

Key Responsibilities

• Collaborate within the Quality Assurance team to ensure products are produced, stored, and packaged following cGMP standards.
• Assist in creating GMP training programs and delivering related training sessions.
• Participate in preparing and reviewing operational procedures and batch documentation.
• Conduct scheduled audits across various departments.
• Ensure effective implementation and maintenance of quality systems.
• Serve as the primary quality contact for systems and processes, offering guidance and feedback on quality-related matters.
• Review documentation, investigations, and reports promptly, highlighting and aiding in addressing concerns based on associated risks.
• Coordinate with departments to ensure timely resolution of quality actions and findings.
• Engage actively in continuous improvement projects.
• Monitor and report Return to Full-Time (RFT)/trend data and collaborate with teams to resolve recurring problems.
• Take part in internal supplier and regulatory audits and contribute to essential quality initiatives.
• Critically review procedures and practices to ensure robustness.
• Support deviation investigations, ensuring all product deviations are resolved before product release.
• Maintain cGMP compliance at all times.

Requirements

• A degree qualification in science or a related field is preferred.
• Between 2 and 5 years of experience in a comparable quality assurance role.
• Proven experience operating within a GMP-regulated environment.

Additional Information

For further information, candidates may contact Louise Mulligan via phone or email. CareerWise Recruitment specializes in placing professionals within life sciences and related sectors across Ireland and maintains strict data privacy policies ensuring candidates' information is handled with consent and confidentiality.