Michael Gameel Eskander

Quality control (HPLC/Stability) SupervisorFull Time

• Job Details:Ten years of experience in: Analysis of several pharmaceutical dosage forms –including syrups, solutions, elixirs, Sterile ampoules, Creams, ointments, gels, tablets, capsules, powders, and pharmaceutical raw materials via: 1. Physical analysis (characters, appearance, solubility, hardness, thickness, friability, disintegration, and dissolution tests. 2. Chemical analysis (identification tests, chemical tests, limit tests, assays by potentiometric means as titroprocessors, volumetric titration, gravimetric assay, water content determination by Karl Fischer instrument, melting point analyzer, pH meters, conductivity meter, polarimeter, refractive index meter, U shape viscometers and rotating viscometers, 3. Instrumental analysis including: A. (High Performance Liquid Chromatography (HPLCs) [Waters Alliance , Shimadzu (model: 2010, and new UFLC models with DAD and RID detectors), Agilent and Merck Hitachi], B. Waters Ultra Performance Liquid Chromatography (UPLC) C. Gas Chromatography (GCs) [ Varian and Agilent] with Limited experience, D. FTIR, E. Ultraviolet Spectroscopy. F. Little experience in Atomic absorption and near IR. 4. Participating in analytical method development (Methodology) 5. Validation and verification of several test methods of analysis, according to USP/NF and ICH Guidelines including: 1. Accuracy. 2. Precision (Repeatability /Intermediate precision). 3. Specificity. 4. Detection limit. 5. Quantitation limit 6. Linearity. 7. Range. Communication skills Good communication skills gained from my experience as a quality control Supervisor in a pharmaceutical plant, dealing with large number of colleagues in different departments. Organisational / managerial skills ▪ Management the stability study system (Long term & Accelerated) for different dosage form including (study planning , analysis , follow up and data collection, results recording , printing and archiving of data records) ▪ Responsible for determination and purchasing of Chemical reagents /Flammable solvent. Job-related skills . ▪ Introduced a Gap analysis between laboratory documents &ISO 17025 requirements(studying Standard Operating Procedures- S.O.Ps and comparing them with the standard of ISO 17025) Training courses: A- Attended and completed courses in: 1. Awareness of ISO/IEC 17025:2005 requirement. 2. Validation of Analytical Methods. 3. Basic Statistics for analytical chemistry. 4. Quantifying Uncertainty in Analytical Measurements. 5. Statistical process control (SPC).6. GMP and GLP mini courses. 7. Awareness of ORACLE data base system. 8. Train the trainer mini course. B- Attended but not completed courses(terminated during Egyptian revolution):Eva Pharma Leadership Development Program (ELDP):This program is to develop new potential managers for the near future by enhancing their skills, knowledge and abilities.The program entails the below: - Soft skills courses (Communication, Negotiation and Presentation skills) - Management courses (Becoming a Manager and Project Management) - Courses covering different business functions (Marketing, Human Resources Management, Supply Chain Management and Finance for non Financials) - Miscellaneous courses (Business Writing, dealing with Conflict and Crisis, Setting Smart Objectives, Statistical Process Analysis).I already finished an ELDP course in: ABC of supervisory skills