Quality Control Senior Expert

About the Position

Quality Control Senior Expert

Acino, a leading pharmaceutical company headquartered in Zurich, is seeking a Quality Control Senior Expert to join our team in Dubai, United Arab Emirates. Established in 1836, Acino is part of Arcera, a diversified life sciences holding company, committed to delivering quality pharmaceuticals to promote affordable healthcare in emerging markets.

Responsibilities

• Review and Approval: Review and approve electronic analytical data, analytical batch records, test results, calculations, and analytical reports for accuracy, completeness, and compliance with specifications.
• Compliance Assurance: Confirm that all batches under QC release meet the approved specifications and have no pending deviations, OOS, or OOT.
• Data Integrity: Ensure adherence to cGMP, laboratory SOPs, regulatory standards, and pharmacopeial requirements, and drive improvements in analytical data management.
• Audit Trail Review: Perform audit trail review for analytical instruments and software systems, identifying and addressing anomalies.
• Discrepancy Resolution: Identify and resolve discrepancies in analytical data, and verify instrument performance, method execution, and calculation accuracy before batch disposition.
• Data Security: Ensure all data is traceable, attributable, and tamper-proof, following ALCOA++ principles.
• User Access Control: Ensure user access control compliance, preventing unauthorized data modifications.
• Collaboration: 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.
• Training and Governance: Act as the QC Data Integrity Champion, ensuring DI best practices are consistently followed. Develop and conduct training sessions on data integrity and electronic record compliance for QC personnel.
• Investigation and Improvement: Lead DI investigations in QC, ensuring proper root cause analysis and CAPA implementation. Lead the improvement, revision, and implementation of QC system SOPs.

Requirements

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

We Offer

• Dynamic Environment: Join a very dynamic organization where decisions are taken fast and you can actively participate in shaping our future.
• Professional Growth: Opportunity to work with a global team and contribute to the advancement of affordable healthcare.

About the Company

Acino, part of Arcera, is a pharmaceutical company with a clear focus on selected markets in the Middle East, Africa, and Latin America, as well as Ukraine and Eurasian countries. With over 3,000 people across 90 countries, we deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets. We also leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing.

If this sounds exciting, we would love to hear more about you!

Apply now via our HR system here.