مدير ادارة توكيد الجودة
شركة هوكستر للصناعات الدوائية
Total years of experience :19 years, 7 Months
1-GMP compliance in production area.
2- Active Internal auditor.
3-Validation studies.
4-Annual product review.
5-Batch record review.
6-Change control assessment.
7-Reoprting Non-conformances and investigation of NCRs and
Implementing CAPA system.
8- Supporting Auditors for External and Internal suppliers.
Achievements:
1- Follow up all manufacturing process.(more than 350 batches)
2- Preparing and reporting 20 validation protocols.
3- Trend Analysis for 15 products during Annual product review.
4- Review more than 700 Batch records.
5- Controlling more than 10 change controls in different depts. in the
SAJA Plant.
6- Finishing the related reports for CAPA system.
Responsible for:
1-GMP compliance in production area.
2- Active Internal auditor.
3-Validation studies.
4-Annual product review.
5-Batch record review.
6-Change control assessment.
7-Reoprting Non-conformances and investigation of NCRs and
Implementing CAPA system.
8- Supporting Auditors for External and Internal suppliers.
1-In-process Control Testing
2-Deviations and Investigations
3-GMP Compliance
4-Batch Record Review
5-Creating Standard Operating Procedures
6-Checking Raw Material.
7-Applying Validation Protocols
8-Preparing Trend Analysis for APRs
• Grade: very good