QC/QA Manager, Data Analyst, Certified Lean Six Sigma Black Belt-AUC/IQF, Member in OPEX-Egypt chapter, Auditor Certified in OHSAS
18001, Master in Quality Management MQM
Profile Summary
QC Manager at Artpharma for Pharmaceutical Industries
Member of Operation Excellence Society (OP-EX®) Egypt chapter.
Expertise in quality control operation management, analysis techniques, quality management systems (per ISO 9001-2008,
ISO 17025-2005, cGLP, cGMP, WHO, ICH, FDA and EDQM) in nearly all fields (Raw materials, Packaging materials,
Finished products and Stability studies) and in operation, calibration and validation of nearly most of high tech analysis
instruments (especially HPLC, GC HS, potentiometer, Karl fischer, analytical balance).
Excellent Knowledge with handling quality audits from multinational companies (Pfizer, GSK, Novartis, Sanofi Aventis,
Roch, Ranbaxy) and local companies (such RAMEDA, Hope Pharma).
Expertise in validation of utilities (Water production and distribution systems (including water for injection), Pure Steam
production and distribution systems, Nitrogen production and distribution systems, and compressed air production and
distribution systems).
Proficiency in process improvement methodology (DMAIC) and Lean methodologies (Kanban, Poki-Yoki, 5S..etc).
Proficiency in process control and its tools as control charts, Process capability etc.
Expertise in solving chemical lab problem, troubleshooting and design of new analytical methods.
Technical Skills
Excellent User of Statistical software s: Minitab.
Excellent User of MS Office package: Word, Excel, PowerPoint.
Very Good Knowledge of Oracle®: Database management system support.
Business Skills
Ability to work individual or among team.
Self-motivated with ability to work under pressure.
Very good analytical and interpersonal skills.
Very attentive to details while archiving work, preparing documentation.
Certificates
Certified OHSAS 18001 auditor (HTDS-IRCA).
ISO 17025: General requirements for the competence of testing and calibration laboratories.
Current Good Manufacturing Practice (cGMP) Borg Pharmaceuticals Industries.
Good Laboratory Practice(GLP)" Borg Ph
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