Quality Control Senior Expert

Acino Pharma; Dubai; On-site; AED 223,200 - 334,800; Full time

Job summary

Acino Pharma is seeking a QC Senior Expert in Dubai to ensure compliance with cGMP and data integrity in the QC laboratory. This role involves auditing analytical data and leading investigations to maintain quality standards.

The ideal candidate will hold a Bachelor’s degree in pharmacy, with over 10 years of QC experience, focusing on analytical techniques and electronic data governance.

Qualifications

• 10+ years of experience in pharmaceutical QC, specializing in analytical techniques.
• Strong knowledge of cGMP standards and electronic data governance.
• Experience with audit trails and metadata analysis.

Responsibilities

• Review and approve analytical data for compliance and accuracy.
• Perform audit trail reviews and identify discrepancies in data.
• Develop training sessions on data integrity for QC staff.

Skills

Analytical techniques

cGMP standards

Data integrity

Good Documentation Practices

Root-cause analysis

Education

Bachelor’s degree in pharmacy

Tools

Empower

Labsolution

OpenLab

LabWare

SAP

IQVIA

TrackWise

Job description

The QC Senior Expert is responsible for reviewing and approving electronic analytical data, analytical batch records, and analytical reports to ensure compliance with cGMP, Data Integrity Principles, and regulatory requirements supporting the final QC batch release. The role involves audit trail review, analytical record verification, and metadata assessment, ensuring data accuracy, completeness, and integrity. Additionally, the QC Senior Expert acts as the Data Integrity Champion within the QC laboratory, supporting training, governance and compliance enhancement activities.

Key Responsibilities

• Review and approve electronically generated analytical data, batch records, test results, calculations, and analytical reports for accuracy, completeness, and compliance with specifications.
• Confirm that all batches under QC release meet approved specifications and have no pending deviations, out-of-specification (OOS) or out-of-time (OOT) findings.
• Ensure adherence to cGMP laboratory SOPs, regulatory standards, and pharmacopeial requirements and drive improvements in analytical data management.
• Perform audit trail review for analytical instruments and software systems, identifying and addressing anomalies.
• Identify and resolve discrepancies in analytical data and verify instrument performance, method execution, and calculation accuracy before batch disposition.
• Ensure all data is traceable, attributable, and tamper-proof following ALCOA principles.
• Ensure user-access control compliance, preventing unauthorized data modifications.
• Collaborate with IT and QA to validate electronic data systems for compliance with 21 CFR Part 11, EU Annex 11, and WHO TRS 996 Annex 4.
• Act as the QC Data Integrity Champion, ensuring best practices are consistently followed.
• Ensure all QC staff are aware of Good Documentation Practices (GDP) and electronic data-management policies.
• Lead data-integrity investigations in QC, ensuring proper root-cause analysis and CAPA implementation.
• Identify risks related to electronic and paper-based data handling, proposing effective mitigation strategies.
• Develop and conduct training sessions on data integrity and electronic record compliance for QC personnel.
• Monitor data-integrity deviation trends and provide required information for periodic management review.
• Lead the improvement, revision, and implementation of QC system SOPs.

Qualifications

• Bachelor’s degree in pharmacy. UAE-licensed pharmacist preferred.
• Minimum 10 years of experience in pharmaceutical QC with in-depth knowledge of analytical techniques and batch release activities.
• In-depth knowledge of cGMP standards, audit trails, metadata analysis, and electronic data governance.
• Hands-on experience with analytical instruments, QMS, DMS, and lab-management software (Empower, Labsolution, OpenLab, LabWare, SAP, IQVIA, TrackWise).