Senior Quality Control Expert

About the role

The QC Senior Expert reviews and approves electronic analytical data, batch records and reports to ensure compliance with cGMP, data integrity principles and regulatory requirements, supporting final batch release. The role also acts as the Data Integrity Champion within the QC laboratory, driving training, governance and continuous improvement.

Key responsibilities

• Review and approve electronically generated analytical data, batch records, test results and calculations for accuracy and compliance.
• Perform audit‑trail reviews for analytical instruments and software, identifying and addressing anomalies.
• Ensure all data follows ALCOA++ principles, is traceable and tamper‑proof.
• Collaborate with IT and QA to validate electronic systems against 21 CFR Part 11, EU Annex 11 and WHO TRS 996 Annex 4.
• Lead data‑integrity investigations, root‑cause analysis and CAPA implementation.

Required profile

• Bachelor’s degree in pharmacy; UAE‑licensed pharmacist preferred.
• Minimum 10 years of experience in pharmaceutical Quality Control with strong knowledge of analytical techniques and batch release.

Required skills

• Experience with laboratory software such as Empower, Labsolution, OpenLab, LabWare.
• Familiarity with enterprise systems like SAP, IQVIA and TrackWise.
• Hands‑on experience with analytical instruments, QMS and DMS.