QA Specialist (cGMP)

About the role

Join a leading pharmaceutical company in Ireland as a QA Specialist. You will work within the Quality Assurance team to ensure that manufacturing, storage, and packaging processes meet cGMP standards, safeguarding product quality and patient trust.

Key responsibilities

• Ensure compliance with cGMP requirements across all manufacturing, storage, and packaging activities.
• Develop and deliver GMP training packages to staff.
• Prepare, review, and maintain procedures and batch documentation.
• Conduct scheduled audits of all departments and support internal, supplier, and regulatory audits.
• Act as the Quality Point person, providing guidance on quality issues and system processes.
• Perform timely reviews of documentation, investigations, and reports, addressing risks.
• Collaborate with cross‑functional teams to close quality actions and findings.
• Investigate product deviations and ensure resolution before release.
• Maintain good housekeeping standards and adhere to safety protocols.
• Measure and report Right First Time (RFT) data, addressing recurring issues.

Required profile

• Third‑level qualification, preferably a science degree.
• Minimum 2 years of experience in a GMP‑regulated environment.
• Strong knowledge of cGMP and regulatory compliance.
• Excellent accuracy, attention to detail, and interpersonal skills.
• Proficiency with computer applications and good presentation abilities.
• Flexible, adaptable to change and able to work with minimal supervision.

Required skills

• cGMP knowledge