Quality Control Senior Expert

About the Position

We are seeking a Quality Control Senior Expert to join our pharmaceutical team in Dubai, United Arab Emirates. This role is integral to ensuring compliance with regulatory standards and data integrity within our organization.

Responsibilities

• Review and approve electronically generated analytical data, analytical batch records, test results, calculations, and analytical reports for accuracy, completeness, and compliance with specifications.
• Confirm that all batches under QC release meet the approved specifications and have no pending deviations, OOS, or OOT.
• 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 ensure electronic data systems are validated and compliant with 21 CFR Part 11, EU Annex 11, and WHO TRS 996 Annex 4.
• Act as the QC Data Integrity Champion, ensuring DI best practices are consistently followed.
• Ensure all QC staff are aware of Good Documentation Practices (GDP) and electronic data management policies.
• 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 DI deviations trends and provide required information for Periodic Management Review.
• Lead the improvement, revision, and implementation of QC system SOPs.

Requirements

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

We Are Acino

At Acino, we push the boundaries to deliver high-quality pharmaceutical products that improve patients’ lives. Driven by our collective purpose to provide access to medicines to those in need, our strength lies in our unique expertise and presence in emerging and high-growth markets. We are proud to be challenging the status quo in the pharmaceutical industry, always looking ahead to the future with an open mind.

Join Acino, a dynamic and rapidly growing environment where your contributions can make a real difference.

Acino is an Equal Opportunity Employer.

How To Apply

Please apply via our HR system here. Only direct applications will be considered.

Please Note

Please note that our company name as well as names of members of the management committee are occasionally misused by third parties for scamming, particularly in the context of fake job offers.

We would never ask for down payments in relation to job applications. Should you have any doubt as to the authenticity of a job proposal please contact with us.