Quality Control Senior Expert
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Key skills for this role
About the Role
Established in 1836, Acino, part of Arcera, is a pharmaceutical company headquartered in Zurich, with a clear focus on selected markets in the Middle East, Africa, and Latin Ame.
Key Skills for This Role
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.
- Lead DI 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.
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 (e.g., Empower, Labsolution, OpenLab, LabWare, SAP, IQVIA, TrackWise).
Full Job Posting
Company Overview
- Established in 1836, Acino, part of Arcera, is a pharmaceutical company headquartered in Zurich, 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.
- Acino is part of Arcera, a diversified life sciences holding company, established by ADQ in Abu Dhabi in 2024 with the purpose to advance innovation in line with the Emirate's 2030 vision for the sector and beyond.
Key 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.
- Lead DI 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.
Qualifications
- 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).
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