Regulatory Affairs Associate Director
Merck sharp & Dohme
مجموع سنوات الخبرة :14 years, 2 أشهر
Regulatory affairs responsibilities
1- Upheld service standards for counseling, dispensing, pricing, licensing, managing inventory, and record keeping.
2- Provide prescribed medications, drugs, and other pharmaceuticals as needed for adequate patient care.
3- Conduct Drug Regiment Review on all patients.
4- Ensured that every customer received friendly, knowledgeable, and efficient service.
5- Checked all work done by pharmacy technicians prior to dispensing medications.
6- Effectively managed conflict to achieve desired business results.
7- Worked with other members of the pharmacy to ensure accuracy of prescriptions.
The RM/MSM is a key person to manage material supply (all logistics related activities) in a way to minimize the losses in total Supply Chain. The purpose of the role is to ensure 100% Raw Material availability for production while minimizing the total cost for the company (Raw Materials Inventory, Remnants, Transportation cost) as per Cairo CBN - fully leveraging SAP R3 potential.
RESPONSIBILITIES
1. I was responsible for materials ordering by placing Purchase Orders to suppliers through SAP.
2. I was responsible for suppliers’ management including regular meetings, scorecards and agreement (SLEA) updates, as I was the main contact with suppliers
3. I was responsible for logistic Operation and internal communication within Cairo plant with all involved functions (Lab, Operations, TSG, WH, GMDSO, etc)
4. I was responsible for Inventory management - analyze inventory structure and identify opportunities for inventory reduction on monthly basis.
5. I was responsible for Raw Material phase out / phase in co-ordination with initiative leader in order to minimize RM remnants.
6. I had the rule to follow Raw Material allocation as per Regional Purchasing and Regional material supply management guidance.
7. Maintain SAP R3 Master Data and owns the BOM audit result.
8. Perform on quarterly basis MIM (material inventory management) calculation and update SAP R3 Master Data accordingly.
9. Own improvement of one (or more) SERPAT (Site Enterprise Resource Planning Assessment Tool) measure and on monthly basis conduct gap analysis using PDCA (Plan -DO-Check-Act) cycle logic.
10. Invoice Management by ensuring that all supplier invoices are processes timely and accurately.
QC Specialist Hikma Pharmaceuticals:
1- Analysis of Bulk, Semi Finished & finished product using HPLC, GC, UV& atomic absorbance.
2- Analysis of IPC samples (pH, density, instruments water of cleaning)
3- Data entry through SAP.
4- Instruments used in the analysis:
• HPLC Waters
• GC Agilent
• UV schimadzu
• Dissolution, disintegration, friability, hardness.
• Near IR Agilent
Faculty of pharmacy Frade: Good