wael maklad

QA Senior Section Head at ADWIA

• Egypt - Cairo
• My current job since September 2002

* Key Responsibilities:

□ Leading site QA operations team and effectively implement quality management systems.
□ Responsible for Line clearance, In-process quality checks.
□ Environmental monitoring, GMP utility systems quality sampling and product sampling management.
□ Collaborate with other departments (QC-Manufacturing-Planning-Engineering-Validation) to ensure product quality and monitor site KPIs.
□ Complete the customer complaint & investigate all documents needed.
□ Review & inspection of primary & secondary packaging materials
□ Follow up Release, Rejection, Destruction of all materials & products.
□ Insure that the system of document is completely controlled & applied.
□ Operating & testing by IPC devices ( Erweka Leak tester - Moisture content - Erweka Disintegration tester - Erweka Hardness tester - Pharmatest disintegration tester - Pharmatest Hardness tester - Friability Hardness tester - WTW pH/Cond meter - WTW conductivity meter - WTW pH meter )
□ Responsible for CAPA implementation and monitoring its effectiveness.
□ Batch Review through performing a periodic quality review on batch documentation..
□ Insuring that the last version of printed packaging material is applied.
□ Participation in Internal and Regulatory audits and assure site readiness for the GMP audits.
□ Responsible for On - Job training for new hiring.
□ Responsible for review and approval of product release.
□ Controlling of the following processing areas:
* (Tablets, capsules, sterile vials, Ampoules, syrup, liquid, cream, powder).
* Check the pH & conductivity of purified water & water for injection before formulation process.
* Follow up all stripping, blistering & packaging processes.
* Help to decrease amount of loss.
* Follow up dispensing stage for the raw materials.
* Follow up chemical stores, raw material analysis.
* Water station.