Section head in QC
Amipharma laboratory
Total des années d'expérience :23 years, 5 Mois
Work in QC as chemist supervisor investigation of OOS, deviation, incident and change control.
Preparing all SOPs in QC, member in GLP Group and and Reviewing COA
2012
Workshop of Bioequivalence and bio waiver: the concept, conduct and
Training course in cGMP (Contamination, Cross Contamination and Mix-up
Training course in cGMP (Hygiene and Sanitation
Instrumentation and control system& Calibration Troubleshooting& Maintenance
Instrument Handled
. HPLC, GC, AAS, Flame photometer.
. UV/VIS Spectroscopy, IR, Polar meter
. Dissolution apparatus.
. KARL FISCHER TITRATOR.
. Autotitrator METTER.
. Specific optical rotation
of the Quality Control, I was responsible for implementing the production daily programme; based on cGMP and GLP standards; by distributing daily programme activity, controlling and supervising the different stages of the analysis process. I was also responsible for supervising number of operators and scheduling the maintenance regular check up in the Quality Laboratory. I also helped writing and applying the Standard Operating Procedures (SOP). I served as a deputy head of the quality control section for a period of 2005 up to now.AS senior analyst I perform analysis stability study, writing stability SOPs and protocol and calibrating the instrument. Also analysis water for pharmaceutical purpose.
Reviewing certificate of analysis COA and develop, validation method for analysis especially stability indicating method.
My current job served Quality management system.as lead investigator.
I was a member of the senior staff who helped the company win the ISO 9001 award 2002.
Ph.D chemistry Analytical chemistry ( Pharmaceutical analysis)