Quality Assurance Specialist

Role Summary

We are seeking a Quality Assurance Specialist for a biopharmaceutical company located in Waterford. This role involves working on-site within the Quality Assurance team to ensure that products are manufactured, stored, and packaged in strict adherence to current Good Manufacturing Practices (cGMP).

Key Responsibilities

• Collaborate within the QA team to verify compliance of manufacturing, storage, and packaging processes with cGMP standards.
• Assist in creating and delivering GMP training programs.
• Participate in drafting and reviewing standard operating procedures and batch records.
• Conduct scheduled audits across all departments to ensure quality compliance.
• Maintain and enforce effectiveness of the quality management system.
• Ensure all practices satisfy cGMP regulatory requirements.
• Serve as the quality point of contact for systems and processes, offering advice and feedback on quality issues.
• Review documentation, investigations, and reports promptly, identifying and aiding resolution of issues based on risk assessment.
• Coordinate with different departments to guarantee prompt closure of quality actions and findings.
• Contribute proactively to continuous improvement activities within the company.
• Perform responsibilities adhering to workplace safety guidelines and report any safety concerns immediately.
• Gather and report Right First Time (RFT) and trend data, collaborating with departments to address recurring challenges.
• Engage in internal supplier and regulatory audits and participate in critical quality initiatives.
• Critically evaluate procedures and practices to ensure compliance and quality enhancement.
• Support investigation of deviations to confirm closure of all product deviations before product release.
• Constantly ensure adherence to cGMP requirements at all times.

Required Qualifications and Experience

• A degree or third-level qualification in science or a related field is preferred.
• At least two years of experience in a comparable quality assurance role.
• Proven experience working within a GMP-regulated environment.
• Strong understanding of cGMP standards within a regulated setting.
• Exceptional attention to detail and accuracy in all tasks.
• Strong interpersonal skills and an ability to present information effectively.
• Competency in common computer software packages.
• Adaptability and comfort with ongoing organizational changes.