QC Reviewer – Pharmaceuticals
📍 Location: Cashel, Co. Tipperary
💼 Work Setup: 5 days a week, fully onsite
🕒 Job Type: Permanent
💰 Salary: Competitive + Great Benefits
🏭 Industry: Pharmaceuticals / Biopharmaceuticals
About the Role
A leading pharmaceutical company in Cashel is hiring a QC Reviewer to ensure the accuracy, compliance, and integrity of quality control (QC) laboratory data. This permanent role offers excellent benefits and the opportunity to play a key part in maintaining cGMP and regulatory standards.
Key Responsibilities
🔹 Analytical Data Review:
- Review QC data from HPLC, GC, KF, UV, and other analytical instruments.
- Verify calculations, chromatographic integrations, and system suitability results.
- Identify and escalate data discrepancies, deviations, and Out of Specification (OOS) results.
🔹 Electronic System Oversight:
- Conduct audit trail reviews for electronic systems (Empower, LIMS) to ensure data integrity.
- Identify unauthorized changes, missing data, or system anomalies.
- Act as a superuser for Empower/LIMS, providing troubleshooting support and training.
🔹 Compliance & Documentation:
- Ensure GDP, cGMP, and regulatory compliance in all reviewed documents.
- Support data integrity investigations, lab errors, and deviations.
- Assist in regulatory inspections and internal audits by ensuring proper documentation.
🔹 Training & Continuous Improvement:
- Train QC analysts on data review best practices and audit trail review requirements.
- Contribute to process improvements in QC documentation, electronic systems, and compliance.
Key Requirements
✔ 5+ years of experience in pharmaceutical drug product testing.
✔ Hands-on experience with electronic systems (Empower, LIMS, etc.).
✔ Expertise in HPLC, GC, KF, UV, and other QC analytical instruments.
✔ Strong knowledge of cGMP, GDP, and regulatory requirements.
✔ Experience in regulatory inspections and internal audits.
✔ Excellent attention to detail, problem-solving skills, and the ability to train others.
Why Join?
✅ Permanent role with a leading pharmaceutical company.
✅ Great benefits package and long-term career progression.
✅ Be a key player in ensuring data integrity and regulatory compliance.
📩 Apply Now
If you meet the criteria and are ready for your next challenge, apply directly through the link
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