A key role in ensuring data integrity and regulatory compliance has become available at a leading pharmaceutical company. This permanent position offers excellent benefits, long-term career progression, and the opportunity to play a key part in maintaining cGMP and regulatory standards.
Key Responsibilities
* Analytical Data Review:
o Review QC data from HPLC, GC, KF, UV, and other analytical instruments.
o Verify calculations, chromatographic integrations, and system suitability results.
o Identify and escalate data discrepancies, deviations, and Out of Specification (OOS) results.
* Electronic System Oversight:
o Conduct audit trail reviews for electronic systems (Empower, LIMS) to ensure data integrity.
o Identify unauthorized changes, missing data, or system anomalies.
o Act as a superuser for Empower/LIMS, providing troubleshooting support and training.
* Compliance & Documentation:
o Ensure GDP, cGMP, and regulatory compliance in all reviewed documents.
o Support data integrity investigations, lab errors, and deviations.
o Assist in regulatory inspections and internal audits by ensuring proper documentation.
* Training & Continuous Improvement:
o Train QC analysts on data review best practices and audit trail review requirements.
o Contribute to process improvements in QC documentation, electronic systems, and compliance.
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.
About this Role
This is a permanent position that offers excellent benefits and long-term career progression. The successful candidate will have the opportunity to play a key part in maintaining cGMP and regulatory standards.