QA Specialist

Are you ready to safeguard quality, ensure compliance, and make a real impact in a GMP-driven environment? Proclinical is seeking a QA Specialist to join a dynamic team in ROI. In this role, you will play a key part in ensuring that products are manufactured, stored, and packaged in compliance with cGMP standards. This position involves supporting quality systems, conducting audits, and contributing to continuous improvement initiatives.

Responsibilities

Support the development and delivery of GMP training packages; Prepare and review procedures and batch documentation; Conduct audits across departments according to an agreed schedule; Ensure the quality system is effectively implemented and maintained; Act as a quality point of contact for systems and processes, providing guidance on quality issues; Review documentation, investigations, and reports in a timely manner, addressing concerns based on risk; Collaborate with departments to ensure timely closure of quality actions and findings; Contribute to continuous improvement initiatives and report Right First Time (RFT) data trends; Participate in internal, supplier, and regulatory audits; Perform critical reviews of procedures and practices; Investigate deviations and ensure all product deviations are resolved before release; Maintain compliance with cGMP requirements at all times; Adhere to safety protocols and maintain good housekeeping standards.

Requirements

Experience in a similar role, ideally within a GMP-regulated environment; Strong knowledge of cGMP and regulatory standards; Excellent accuracy, attention to detail, and interpersonal skills; Proficiency in computer applications and good presentation skills; A flexible approach and ability to adapt to ongoing changes; Self-motivated, results-driven, and able to work with minimal supervision.

Nice to have

A degree in science or a related discipline is preferred