QC Reviewer New
2 weeks ago
? 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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