DR. AHMED ABDULKADER

Experience

• 

  Otsuka Pharmaceutical Companies (U.S.)

  Jan 2009 - May 2017

  • BFS (blow fill seal ) system validation • Media Fill Processes.• IPC (Dispensing, Preparation, Filling and Packing).• Disintegration, friability, Thickness and Hardness) Tests.• MET ONE 3400, Particular Matter Test. • SIP validation .. Cleaning validation.• Internal Auditor.• BR Review.• Customer Complaint.• recall experience • Equipment qualification (DQ, IQ, OQ ,PQ )• process validation H VAC validation • ISO 9001 and 14001 experience Show less

  • Senior Production Supervisor

    Feb 2015 - May 2017

  • Q.A senior

    Jan 2009 - Jan 2015
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  Sama alfayhaa phramaceutical company

  May 2018 - Oct 2019

  QA Manager

  1- I have established robust QMS in the company.2- I have established complete and harmonized documentation system.3- I have established compliance department handle all compliance activities (deviation management, customer complaints, CAPA management, change control, internal audit, supplier qualification, regulatory audits,.... etc).4- Improve the IPC rules in solid, semi-solid and liquid pharmaceutical dosage forms.5- Lead the company to get certified ISO 9001:2015 on 2018.6- Lead the company to achieve class (A) according to the Iraq MOH annual classification (2018).7- Lead the company to be the first company certified for authority to release its products directly to the Markets. (2019).8- Improve the RA and ART work program.9- Training waves resulted in enhancement in the capabilities and knowledge of the team which reflected on their duties.10- Implementing validation master plan and exciting validation wide program includes, cleaning validation, process validation, H VAC validation, holding time,...etc.11- Implementing thermal mapping studies for the storing areas.12- Implementing program for equipment qualification. Show less

• 

  EPx Logistics

  Nov 2019 - Dec 2022

  Quality Assurance Compliance Manager

  1- Managing team responsible for implementing and handling all compliance activities (Deviation management, customer complaints, CAPA management, Internal audit, external and regulatory audits, supplier qualifications, KPIs and quality objectives.2- Lead the company for successful surveillance ISO audits for three years (9001:2015, 14001:2015 and 45001:2018).3- lead the company for successful audits for three years for most of pharmaceutical multinational companies (Novartis, Sandoz, Roche, GSK, Pfizer, Viatris, Lilly, Medtronic, Clinart, Simens, Jamjoom pharma, Alcon, Merch, Grifols, Apotex, Sysmex, Chiese, Zoetis, Paraxel, MSD, Elanco, Avon, Dow and Sanofi aventis).4- Lead and participate in many of continual improvement projects (electronic QMS, RBA, JDE and SAB integration, lean process, enhance effectiveness of training program). Show less

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  Pharmaceutical indutries

  Dec 2022 - now

  Director of Quality Assurance

  - Establishing the site master file, quality manual and quality policy of the company.- Establishing the documentation and training systems in the company.- Establishing the QMS in all departments of the company.- Water system qualification and validation (phase I, phase II and phase III).- H VAC and clean room qualification.- Establishing qualification, calibration systems.- Thermal mapping of all warehouses.- Establishing the preventive maintenance system.- Successfully opening the liquid and solid lines of the company.- Process validation for liquid and solid lines.- Leading the company to get certified ISO 9001:2015.- Show less