QA Specialist

Job Overview

A pharmaceutical company in Waterford is seeking QA Specialists to join their Quality Assurance team onsite. The position involves ensuring all products are manufactured, stored, and packaged following current Good Manufacturing Practices (cGMP).

Key Responsibilities

• Contribute as part of the Quality Assurance team, enforcing cGMP compliance in all manufacturing and packaging activities.
• Assist in developing and delivering GMP training modules to staff.
• Prepare and review procedural documents and batch records critically.
• Conduct audits across departments according to planned schedules to maintain quality standards.
• Ensure quality systems at the facility are implemented effectively and maintained consistently.
• Address quality issues by acting as a point of contact for systems and processes, providing guidance and feedback.
• Review documentation, investigations, and reports promptly, highlighting and aiding in resolving quality concerns based on risk prioritization.
• Collaborate with departments to ensure timely closure of quality actions and findings.
• Drive continuous improvement initiatives through active participation.
• Adhere to safety protocols and promptly report any safety issues or concerns.
• Maintain excellent housekeeping and organized work areas.
• Attend the workplace as required and participate in team meetings and goals.
• Monitor and report metrics such as Right First Time (RFT) and trends, working with teams to address recurring issues.
• Engage in internal supplier and regulatory audits, supporting key quality initiatives.
• Perform critical reviews of procedures and practices to enhance quality.
• Support investigations of deviations; ensure all product deviations are resolved before product release.
• Uphold cGMP compliance at all times.

Qualifications and Experience

• Possess a third-level qualification, ideally a degree in science or a related field.
• Have at least two years of experience in a similar quality assurance role.
• Prior experience in a GMP-regulated environment is essential.
• Strong understanding of cGMP requirements in a regulated pharmaceutical setting.
• Exceptional attention to accuracy and detail.
• Excellent interpersonal and communication skills, including presentation abilities.
• Proficient with common computer software applications.
• Adaptable and open to ongoing changes within the work environment.