Quality Manager
ATCO Pharma
مجموع سنوات الخبرة :22 years, 3 أشهر
Responsible for QC and QA and all Quality System
Responsible for compliance with GMP and ISO standards
During my work in SIGMA I was responsible for:
1- Supervise the lab operations including inspection
checks and tests on raw materials, packaging
materials, intermediate products, and finished
products according to Q.C. procedures.
2- Check the proper and complete information has been
filled in Q.C. Records and forms according to Q.C.
Instructions.
3- Checking with Signing Analytical Worksheets &
Reports.
4- Contribute in investigation of any out of
specifications results and determine the causes of
faulty analytical results.
5- Follow up the consumption rates of laboratory
materials, equipments & Lab-ware and write purchase
orders for laboratory needs.
6- Supervise the training programs of the new lab
staff.
7- Follow up instruments calibration plan and
Analytical Methods Validation plan.
8- Follow up the requirements of external audits from
Ministry of Health or other consumers..
I have gained a very good
experience in:
1- Analytical Techniques such as: HPLC, GC, UV, FTIR,
KF, TLC, Auto titrations, testing methods, physical
testing of products, …
2- Lab Documentation, SOPs, validation of analytical
methods and calibration processes.
3- Raw Material analysis.
4- Preparation of secondary standards & providing them to all laboratory stuff.
Certified Internal Auditor, American University of Cairo2007.
Certified HPLC analyst, EGAC certificate (ISO 17025).
Understanding &Implementing the requirements of ISO/IEC 17025.
TQM Techniques general course, 2007.
Level 12 in English(American University of Cairo2007).
Uncertainty calculation & control charts techniques, EQE, November2006.
Completion of level 7 in French language(CFCC), 2006.
Five certificates in computer, all are with EXCELLENT grade.
One month complete course in Clinical Pharmacy, 2006.
Certificate of training on Agilent HPLC Instruments, 2006.
Clean area experience
74.5% GOOD