Ahmad Baqazi

Experience

• 

  Arab Company for Pharmaceutical Products ARABIO

  May 2014 - May 2017

  • Jan 2016– now: Arab company for pharmaceutical product (Arabio) as: QA officer. Responsibilities include :Issuance, Archival, Retrieval of documents and Labels including but not limited to:  SOPs Masters and obsolete SOPs. Masters Specifications and Test Procedures. Completed Deviations, Out of Specification Reports & Ems. Completed Change Controls & CAPAs report. Writing bill of materials (BOM) of the products. Completed Audit Reports and Responses.  Batch Records: issuance, reviewing, identify and define the status Labels. Prepare database for archival and retrieval of documents. Artwork management: Creation, approval/obsolete, retention and control for printed packaging materials artwork. Show less • Quality control Microbiologist analysis. Responsibilities include : Preparation of microbiological media & Growth Promotion Test (G.P.T). Bacterial Endotoxin Test (B.E.T) for Water Samples (WFI), R.M, Bulk products & Finish products. Sterility test & Validation the sterility test. Environmental Monitoring for Cleaned Areas (Vial Filling Area) & Packaging Area. Bioburden Test for Water Samples (Filtration & Pour plate Methods) R.M, Bulk products & Finish products. Identity Test of antigens by using ELISA, agar diffusion and electrophoresis method.  Microbial identification for all microorganisms that obtained by VITEK2 id. System.  Gowning Qualification for all operators work in clean areas (Class A&B). Following up the Media Fill Process and Visual Inspection for filled vials. Testing and recovery assuring for all Biological Indicators that used in the plant. Analysis of secondary packaging materials.  Discard all biohazard and contaminated plates & media by autoclaving. Calibration of Micropipettes, Microplate reader and Microplate washer. Inventory management of Media, reagents and accessories.  Disinfectants preparation.  Handling of Change control, deviation OOS etc. Creation of new study protocols, to ensure successful implementation of protocol and generation of study reports etc. Show less

  • QA Officer

    Jan 2016 - May 2017

  • Quality Control Analyst

    May 2014 - Feb 2016
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  Savola Group

  May 2017 - Jan 2019

  QA Management & NPD Officer

  - standards set forth in SOP and cGMP.- Write SOPs , STP , Polices and work instructions .- Assess and ensure compliance with cGMP and company compliance plan against internal (policy/procedure) and external (contract/program) requirements; report regularly on results .- Develop and maintain food safety plans (HACCP), as well as performing the function of active team leader . - Conduct food safety and quality training in various formats to meet the needs of the employees within the parameters of their positions to consistently produce employees who are well trained in the skills and requirements of their position.- Provide guidance and leadership up to and including operations management in situations where deviations have occurred or a potential risk has been identified related to food safety and/or quality . Show less

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  AbbVie

  Feb 2019 - Jul 2022

  Quality Assurance Specialist

  1- Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products.2- Assist in the design of effective quality systems, procedures and/or processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality systems. 3- Evaluate, analyze and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.4- Perform assessments to determine compliance with processes, procedures, and regulations to identify potential gaps and mitigate and implement improvements. 5- Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.6- Establish training requirements and maintenance of a diverse and agile cross-trained and effective team to ensure business continuity and compliance.7 - Coordinate and investigate quality events such as deviations, non-conformances, product complaints and corresponding action plans including decisions. 8- Initiate investigation with manufacturers and to ensure suitable investigations are carried out on samples.9- To deal with Regulatory bodies as required through using complaint reporting processes.10- To maintain and operate the QA complaints system for both imported and manufactured products and prepare suitable customer replies. 11 - Quality management of supplier qualification program including performance monitoring for key suppliers.12 - Responsible for carrying out a quality self-inspection program within the affiliate.13- Coordinate the change control process to ensure changes do not introduce negative impacts to the operation. 14 - Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments. Show less

• 

  Acino

  Jul 2022 - Sept 2023

  Quality Assurance Manager
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  Sandoz

  Sept 2023 - now

  {وَمَا تَوْفِيقِي إِلَّا بِاللَّهِ ۚ عَلَيْهِ تَوَكَّلْتُ وَ إِلَيْهِ أُنِيبُ}I'm excited to announce that I was promoted to Quality Assurance Manager for the Levant, Gulf, and Kingdom of Saudi Arabia (KSA) regions at Sandoz ✨

  • Quality Assurance Manager

    Feb 2024 - now

  • Quality Assurance Manager

    Sept 2023 - now