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Quality Control Manager

Location:
Egypt
Posted:
May 11, 2014

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Resume:

PERSONAL DATA:

•Date of birth: March **nd, ****

•Nationality: Egyptian

•Driving license: Valid

•Military service: Permanently Exempted

CAREER OBJECTIVE:

Looking forward to expand my experience and skills in a reputable organization where my talents and knowledge can be explored

EDUCATIONAL BACKGROUND:

•Bachelor Degree of Pharmaceutical Sciences

Faculty of Pharmacy, Ain Shams University, Cairo, Egypt, May 2009

•Grade: “Excellent with Honors Degree”

•Graduated From: Saint Fatima Language School – El Hegaz Campaign

WORK EXPERIENCE:

•December 2009, working for EIPICO pharmaceutical company, 10th of Ramadan as Quality Control analyst.

•March 2010 till September 2013, working for SANOFI Egypt, El Massaneh st., Zeitoun as Quality Control analyst fully responsible for the Materials section.

•September 2013 till now, working for SANOFI Egypt, El Massaneh st., Zeitoun as Quality Compliance Officer fully responsible for Lab machines qualification and calibration.

•LEAN Project team leader responsible for LEAN implementation in Quality control laboratories (Chemical, Microbiology & Cephalosporin) all over SANOFI Cairo site.

POST GRADUATES STUDIES:

•Total Quality Management (TQM) Diploma since September 2013 at AUC, Egypt.

TRAINING EXPERIENCE:

•LEAN and SIX Sigma on June 2013 at The American Chamber, Cairo, Egypt.

•Basic Management Skills on November 2012 at The American Chamber, Cairo, Egypt.

•LEAN Lab principles workshop on November 2012 at SANOFI Casablanca, Morocco.

•LEAN Lab orientation on May 2012 at SANOFI ZENTIVA, Prague, Chez Republic.

•Industrial pharmacy on August 2008 at Servier Egypt.

•Medical and marketing skills on August 2007 at Sanofi Aventis Egypt.

TECHNICAL SKILLS:

Have the experience of the following:

•Operation, and qualification of: HPLC Waters alliance, Agilent 1100 & 1200 systems, UPLC Aquity system, GC Agilent 6890N system, RAMAN spectroscopy Karl fischer, potentiometer, FTIR, UV (Agilent, Schimadzu, Perkin Elimer and Beckman) spectrophotometer,Votsch stability cabinets and a wide variety of lab instruments.

•Routine and stability analysis (raw materials and finished products).

•Sampling process of materials and full responsibility for monitoring, ordering and handling of Chemical reagents.

•Software validation of various computerized systems.

•SAP and Athena systems.

•E-shopping system for purchasing.

•Phenix system for deviations and change control.

•Overview about LIMS.

RESPONSIBILITIES OF CURRENT POSITION:

•Perform calibration process for all in-house calibrated equipment.

•Follow up outsources calibration schedule for QC equipment related to agents.

•Insure complete adherence to calibration due dates.

•Set up preventive maintenance program for QC CDS (Chromatographic Data Systems).

•Computing risk assessment for all LAB computerized systems' software.

•Validation of software of various LAB computerized systems.

•Issue & Update of All QC Equipment’s SOPs.

•Prepare all documentations required by Registration department for MOH submission.

•Prepare all MOH Analysis requirements (Reference Standards, Raw Materials Sampling, and COAs for either products and or materials).

•Prepare Stability requirements for MOH submissions.

•Analytical assessment for new materials & new products submitted by Business Development Unit as well as issuing and receiving purchasing requests for its requirements.

•Conducting GMP training for all Quality Staff.

•CAPA and Change control management.

•Perform Analysis for any problematic new products or materials and develop their methods as an expert analyst.

•Share in any OOS related to finished products or materials as a second expert analyst.

•Determine quality CAPEX Plan, prepare URS (User requirements) and request offers for comparative study with QC manager as well as ordering and receiving of Quality CAPEX items.

•Prepare order, receive and monitor all QC Laboratories Chemical reagents.

•LEAN Project team leader responsible of LEAN implementation among SANOFI Cairo site QC Labs.

•Implementing and sustaining 5S & +QDCI LEAN Tools.

•Conducting Process mapping for products to detect the different MUDAS and improve their processes.

•Calculating OEE for production machines (including packaging lines) and conducting SMED analysis.

•Conducting VSM to detect processes bottle neck for continual improvement.

•Developed visual management tool for the calculation of HPLCs capacity Utilization among Africa Middle East zone.

SKILLS & HOBBIES:

•Fluent English.

•Computer skills (MS Word, Excel, Power Point, Surfing Internet).

•Passionate about reading and listening to music.



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