
Abanoub Saeed Tawfils
السلام
Marg, Cairo, EgyptWork Experience
R&D Section HeadFull Time
Marcyrl
Dec 2018 - Present -6 yrs, 7 months
Egypt , Cairo
- Job Details:-Reviewing registration files and pilot request before sending to Egyptian drug administration(EDA). -Following up and reviewing formulation trails and results ensuring to reach CQA,CQM & CPP before reaching pilot batches,scale up and create PBRs till process validation of the first three production batches in accordance with QA. -Reviewing new method validation protocol and report ,follow up validation results including their metaphase data till method transfer to QC department or other outside receiving unit(export) ensure its validity through issuing method validation/transfer report as per EMEA/USP guideline for registration purpose. -Cooperate with different departments (warehouse ,Production ,Quality Control , Quality assurance and Purshasing ) ensuring correct Technololgy transfer of both MOAs and PBRs epically pharmaceutical development part during external auditing. -Ensure that the appropriate comparative files are well done for submission to MOH and eCTD files ensuring efficacy of product. -Reviewing Stabilities studies and eCTD files include S-Part and P-Part, ensuring that the appropriate documents which required for registration process in Egypt and export (eCTD) are well done and submitted at appropriate time. -Reviewing updated SOPs and new MOAs , ensure that the current practices are in accordance with the written procedures which should reflect the cGLP and its verification or Method transfer ensuring its validity and that it is covering quality target of the product. -Follow up on weekly base R&D department Plan including Stability studies and R&D trails analyses with Supervisors ensuring progression of our new product development plan parallels to company vision. -Following up annual qualification and maintenance schedule for All Lab Instruments and utilities to ensure the proper work. -Following up chemical reagents and HPLC columns Stock and reviewing and evaluating PO for new brand Suppliers avoiding stock depletion ensuring work flow especially for regulatory needs (new products). -Following up and auditing that all processes in the lab in accordance with cGMP ,GDP and GLP requirements. -Ensuring that all staff are well trained to perform their tasks and continuously improvement their careers path. -Ensuring that all Health & Safety Procedures and other legal requirements must be followed.
Senior R&D Methodology SpecialistFull Time
Chemipharm
Mar 2014 - Dec 2018 -4 yrs, 9 months
Egypt , Giza
- Job Details:Responsible for: Methodology and Validation of finished new APIs Products (on both UV,HPLC) of all dosage forms,verify and updated old one. Establishing export registration file according to their accepted limits(ICH,USP or BP) and also NODCAR file for Local registration including (Method validation and stability studies,comparative dissolution studies). Support stability Plan through full analysis(chemical and physical) of new products . Analysis of new APIs trails for developing new formules and investigate problem with production batches for better one. Analysis of raw material of new APIs that is purshesed for new products and retest old one according to Chemipharm Policy. Responsible for Lab Chemical consumable reagents including their MSDS & COA. Following up the laboratory instruments and utilities including their calibration,maintenance and annual PVT and ensure GDP and GLP. Trainee junior analyst to ensure proper work and best acheivement for company objectives.
Production ChemistFull Time
Evapharma
Jan 2013 - Mar 2014 -1 yr, 2 months
Egypt , Giza
- Job Details: Batch receiving record after reviewing the Production Manager of Associate Administration BR follow-up processing and cleaning kits weight with Associate Store RM according to the instructions on the operation and cleaning of production equipment. follow-up and tracking discrimination according to the product to make a distinction and tracking Batch log write with the Department of Quality Assurance and stores and see the modifications that may occur in the Batch Record After discussion of the Production Manager provide personal protective tools and follow-up attendance of employees belonging to him as well as uniforms Exchange batches on Oracle Applications
Education
College Diploma in Biochemistry
Ain Shams University (ASU)Jan 2011 - Jan 2012 - 1 Year
BCs Science in Chemistry/Biochemistry
Ain Shams University (ASU)Jan 2007 - Jan 2011 - 4 yr
High School - Thanaweya Amma
Ahmed OrabyJan 2007
Languages
Arabic
FluentEnglish
AdvancedFrench
Intermediate
Training & Certifications
CQM/OE
Valor Egypt·2024MBA
Canidian academy·2013GMP
Evapharma ·2013CAPA,Deviation
Evapharma ·2012Chromatography
Ain Shams University·2011