QA Specialist

About the Role

Join Proclinical Staffing as a QA Specialist based in Waterford, Ireland, where you will play an essential role in upholding product quality and regulatory compliance within a GMP-driven environment. Your work will ensure that manufacturing, storage, and packaging processes fully adhere to current Good Manufacturing Practices (cGMP), while actively supporting quality systems and continuous improvements.

Key Responsibilities

• Assist in creating and facilitating GMP training programs.
• Draft and evaluate procedural documents and batch records.
• Perform scheduled audits across various departments to ensure compliance.
• Guarantee effective implementation and upkeep of the quality management system.
• Serve as a primary quality resource for system-related issues, offering expert guidance.
• Timely review of documentation, investigations, and reports, prioritizing concerns based on associated risks.
• Work collaboratively with departments to ensure prompt resolution of quality observations and corrective actions.
• Drive continuous improvement initiatives and monitor Right First Time (RFT) performance trends.
• Engage in internal, supplier, and regulatory inspections and audits.
• Critically assess procedures and operational practices.
• Investigate and manage deviations to guarantee product release only occurs when deviations are resolved.
• Maintain ongoing compliance with all cGMP standards.
• Follow safety guidelines rigorously and promote excellent housekeeping practices.

Qualifications and Skills

• Degree in a science-related field preferred.
• Previous experience in a role within a GMP-regulated setting is advantageous.
• In-depth knowledge of cGMP and related regulatory requirements.
• Strong attention to detail with excellent accuracy and interpersonal communication skills.
• Competency with computer applications and capability to present information effectively.
• Demonstrates flexibility and adaptability in a changing work environment.
• Self-driven and results-oriented with the ability to work independently.

Additional Information

If you require assistance with your application or have any inquiries, you may contact Dean Fisher via email at [email protected].

Proclinical Staffing acts as an Employment Agency for this vacancy. Applicants confirm understanding of the privacy policy regarding data handling when submitting their application.