Solids PU- Senior Quality Compliance Specialist
Novartis PharmOps Cairo
Total years of experience :5 years, 9 months
1. Batch record review.
- Perform batch record review process and conduct both market & technical release activities of finished goods.
- Manage Batch Certificate of analysis through SAP System.
- Review and approve Blank Batch records and Bill of materials.
2. Deviation and complaint handling.
- Investigation of customer complaints & deviations.
- QA Review and evaluation of related deviations and complaints.
- Root cause investigation and rapid root cause analysis.
- Novartis Deviation& complaint certified investigator
3. Change control management.
- Strong participates in Change control management.
- Manage change control records and actions assigned to me.
- Handling and follow up the implementation of the process related Changes.
4. CAPA Handling.
- Ensure that all CAPAs are completed as required.
5. Process and Packaging Validation.
- Review the Process & packaging validation protocols and reports.
- Quality oversight and attending critical process validation steps.
- Participate in Quality risk analysis for process validation steps.
1. GMP auditing.
• Site Local audit programmer manager .
• Auditing Suppliers, service providers and third party contractors as lead auditor.
• Issue auditing plan and report.
• Participate in self inspection and internal audit.
• Follow up the implementation of audit CAPAs
• Issue the SOP (Standard Operating Procedure) for Handling GMP audits.
• Handling Quality Module & Gap assessments related to auditing.
• Perform Risk based Frequency approach for GMP audits on Suppliers.
2. Supplier Qualification.
• Responsible for approving the new suppliers for GXP materials (API, Excipents and packaging materials).
• Issue the SOP (Standard Operating Procedure) for supplier approval and qualification.
• Evaluating the Supplier and monitor their performance
• Handling Change requests, complaints, deviation and issues concerned with quality of supplied materials.
• Handling Quality Module related to supplier qualification.
• Coordinate the Supplier qualification activities between purchase team, QC and Production.
3. Quality Assurance Agreement.
• Responsible for the QA agreement in the site.
• Perform QA agreement with the suppliers, carriers and contractors.
4. Product Quality Review & Process Capability.
• Issue the SOP (Standard Operating Procedure) for PQR & process capability.
• Handling Quality Module related to for PQR & process capability.
• Performing PQRs (Product Quality Review) for drug products .
• Data analysis and trending.
• Root cause investigation for poor process performance.
• Creating Actions arises from PQR recommendation and follow up its implementation
• Act as site process Capability Expert reviewing capability charts in PQRs and data included in Product improvement portfolio.
• Participate in improvement projects raised from PQRs
5. Deviation and complaint handling.
• Investigation of customer complaints.
• Investigation of deviations.
• Root cause investigation and rapid root cause analysis.
• Novartis Deviation& complaint certified investigator.
6. Change control management.
• Strong participates in Change control management.
• Manage change control records and actions assigned to me.
7. Responsible for Training of Quality assurance department.
• Asses the employees needs for training with employees and their direct mangers.
• Issuing Training plan and assure that plan is executed as required.
8. Returned Goods.
• Handling goods returned from market according to Novartis requirements from Quality point of view.
9. CAPA Handling.
• Ensure that all CAPAs (Corrective Actions, Preventive Actions) are completed as required.
10. Lead and participate in projects in areas of yield loss improvement, efficiency, lean processes, metric improvement and quality system improvement.
11. Participate in IQP silver projects and six sigma projects.
12. Employ and champion the use of Quality Risk Management (QRM) and Risk Assessment
(RA) Techniques (e.g. FMEA, Fault Tree Analysis)
13. Provide trend data to support improvements in quality trends for all parameters.
14. Strong Knowledge of Computer system validation and data integrity.
15. Strong knowledge of process validation concept and techniques.
16. Strong knowledge about batch records review and handling.
17. Participated in passing GQO (Global Quality Operation) and MOH (Ministry of Health) audits which passed successfully
18. Ongoing Novartis IQP silver certification.(Lean and six sigma)
Software programs and systems used in performing the daily tasks:
• SAP system.
• Track wise AQW A System.(All modules ), Key user for AQW A audit and AQW A Quality Event.
• Minitab.
• Microsoft Excel, W ord, PowerPoint and Outlook.
Community Pharmacist
