Bassem Elsayed (MSc)

Experience

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  UNIPHARMA Egypt

  Oct 2011 - Jan 2014

  Quality Control Analyst (Stability & Methodology)
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  MedPharm Ltd

  Jan 2014 - Jul 2015

  QC Supervisor
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  Rameda Pharmaceuticals

  Oct 2015 - Jan 2018

  Stability Supervisor

  Developing and searching for appropriate test methods for new drugs using US/EU/FDA Pharmacopeia and/or different Reference. -Method development HPLC UV.-HPLC application Creation Development comparative dissolution profile for new Drug Products.- Validation of method within latest items according to Standards of the Egyptian Ministry of Health.-Method development for in vitro different solvent for standers by using of various Several methods.-preparation different working media 1.2 /4.5/6.8/7.4 according to FDA, USA,P.P Reference.-calibration linear ensure, Calibration& Dissolution preparation for injection in HPLC UV system.-Dissolution system operator.- Purchasing all instruments, equipment's, reference, chemicals, tools, glassware and required for labs.- Supply Chain Management-Handling all Documentation and Reports for the performed analysis.-stability report writing.-Having a good Experience with dealing with the following instruments;HPLC UV, Dissolution Device, concentrator IR, Distillation Device, pH meter and it's calibration, oven, degasser, swiper and sonicator, balance, normal and cooling centrifuge, Hot plate starrer, water bath, vortex Show less

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  INAD Pharma

  Mar 2018 - Oct 2019

  Q.C section head for methodology and stability

  Developing and searching for appropriate test methods for new drugs using US/EU/FDA Pharmacopeia and/or different Reference. -Method development HPLC UV.-HPLC application Creation Development comparative dissolution profile for new Drug Products.- Validation of method within latest items according to Standards of the Egyptian Ministry of Health.-Method development for in vitro different solvent for standers by using of various Several methods.-preparation different working media 1.2 /4.5/6.8/7.4 according to FDA, USA,P.P Reference.-calibration linear ensure, Calibration& Dissolution preparation for injection in HPLC UV system.-Dissolution system operator.- Purchasing all instruments, equipment's, reference, chemicals, tools, glassware and required for labs.- Supply Chain Management-Handling all Documentation and Reports for the performed analysis.-stability report writing.-Having a good Experience with dealing with the following instruments;HPLC UV, Dissolution Device, concentrator IR, Distillation Device, pH meter and it's calibration, oven, degasser, swiper and sonicator, balance, normal and cooling centrifuge, Hot plate starrer, water bath, vortex Show less

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  JEDCO International for Pharmaceuticals

  Nov 2019 - Jun 2022

  Head Of Quality Control

  Quality control section head and methodologyStart up at this is company. Purchasing for all instrument in quality control.Making all different file with different dosage forms and send to EDA.IQ & OQ for all instrument like (HPLC DA, UV, FT-IR, GC, etc.…). Prepare and approved for all SOPs in QC.Make validation protocol.build the new quality system inside QC.Purchasing all instruments, equipment's, reference, chemicals, tools, glassware and required for labs.Supply Chain Management Show less

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  Mash premiere

  Jun 2022 - now

  QC Section Head and Deputy Manager

  1. Implement the project QC Plan. 2. Perform QC reviews for all project submittals.3. Responsible for quality management and coordinating the three phases of control and documentation. 4. Prepare and approved for all SOPs in QC.5. Coordinate and resolve comments on subcontractor Quality Control Plans.6. Prepare and issue overall Inspection Status Report and maintain Test Log and Nonconformance Report Log.7. Member of audit teams to achieve high quality.8-Responsible for all activities of the quality control department, including raw materials, packaging materials, intermediate, finished products, validation, sampling, maintenance & calibration of laboratory instruments and microbiology laboratory as well as stability testing to ensure compendia, company and regulatory compliance. 9- Responsible for daily planning, products testing and releasing by QC.10-Documentation responsibilities included SOPs, specifications, and procedures and stability data review of new and existing products.11-Investigated customer complaints, OOS investigations and troubleshooting of manufacturing and packaging deviations.12-Supported manufacturing and compliance departments in investigations, process validations, deviations and customer audits.13- Managed initial and continuing training for lab personnel and develop employees within the Quality function to ensure an efficient and effective Quality function exists within the company.14 Responsible for writing and/ or reviewing method transfer protocols, reports, Certificate of analysis and SOPs relevant to QC to meet regulatory guidelines and expectations.15 Review and ensure the implementation of Pharmacopoeia updates.16 Purchasing all instruments, equipment's, reference, chemicals, tools, glassware and required for labs.17 Supply Chain Management Show less