Methodology Section Head
unipharma
Total years of experience :15 years, 4 Months
- Developing New Methods of Analysis
-validation of these methods
- supervision of method transfer
- main gas chromatographer and trainer
o Company: Delta Pharma Co. January 2009 - Present
o Address: Industrial Zone B4, 10th of Ramadan City, Egypt
o Department: Quality Control
o Job Title: Instrument and document control unit head.
• As Senior Q. C. Specialist: 1. Analyzing raw materials, primary & secondary packaging materials, Purified Water (PW) and Water for Injection (WFI)
2. Validation of the water purification system.
3. Analyzing of IPC and finished product samples.
4. Issuing the Standard Operating Procedures (sops), preparing the (Design, Installation, Operation & Performance Qualifications "DQ, IQ, OQ & PQ") & supervising the use of different laboratory instruments.
• As instrument and document control unit head.
1. Document Control: o Laboratory documentation including records for laboratory procedures, protocols, technical procedures, training & employees records and instrument qualification documentations
o Responsible for record-keeping and ensuring that up-to-date document is being used and that obsolete documents are removed from use.
1. Sample Handling: o Monitors the shipping, delivery, packaging, and handling of samples and makes recommendations for corrective action when conditions are found that lead to damaged, contaminated, or mis-handled samples received.
2. Performance Reporting: o Makes periodic reports to the quality Director about laboratory output and performance.
3. Equipment Control: o Internal And external calibration of all laboratory instruments
o Maintenance of laboratory instruments internally and externally
o Issuing, revision and updating SOP's for all laboratory equipment
4. Purchasing Procedures: o Advises the purchasing section regarding the quality of purchased chemical reagents, glassware, equipment and purchasing orders following up o Keeps Copies of all purchase orders for testing equipment and materials, chemicals, and reagents to review such orders to ensure that the latest requirements are correctly specified.
o Developing inventory for monitoring chemical reagents, glassware and spare parts stock and demand
5. OOS preventive and Corrective actions: o Guidance and supporting Q.C team during investigation of internal and external audit non conformity reports.
o Following up to see that the preventive and corrective action measures have been completed.
6. Personnel &Training
o Training of new hired employees on different instruments and laboratory techniques.
o Keeping record for training needs and training protocols.
2013 Master of organic chemistry Synthetic heterocyclic Zagazig University
2008 Diploma in Biochemistry & Physiology* Very Good Suez Canal University
2007 Pre-Master in Organic Chemistry Accepted Zagazig University
2004 Bachelor of Science (Special Chemistry) * Very Good Zagazig University
