Experience

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  Globe pharmaceutical group of companies ltd

  Dec 2013 - Dec 2015

  Quality assurance officer

  -Ensure sampling of raw materials and packaging materials as per company procedures. -Review SOPs related to quality assurance and manufacturing activities.-Investigation of market complaints.-Supervise the IPQA activities of manufacturing plant.-Review and release the batch after referring manufacturing and control.-Conduct vendor audit for raw materials/packaging materials and approval of new facilities for manufacturing of our products.-Review and approval of art work of all finished packaging materials. Show less

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  Novartis

  May 2016 - Apr 2020

  Process and cleaning validation specialist

  • Ensure that process validation are performed and are in line with the current Novartis requirements and cGMP.. • Translate the critical process parameters and the process control strategy into a focused validation plan for process validation • Execute process improvements or development , Scale up/trial. • Author validation protocols(e.g: Launches, Transfer, Weak point remediation) • Participate in transfer and launches, liaise with technical developments for new products and align on the process validation approach. Quality Support - Quality Risk Assessment- Product quality Risk Management- Deviation investigation report - Gap assessment of technical documents Cleaning validation - Cleaning Validation risk assessment, protocol & Report - Collection of Cleaning Validation sample - Performing risk assessment for new product - Bracketing and worst case determination .- Establishing dirty and clean hold times and creating product and equipment groupings. Tech transfer- Ensure Technical transfer product activity- TDP review- Resource gap identification and action to resolve gaps during transfer - Technical documents preparation- Process validation activity- Ensure that key procedures (e.g. cleaning validation) are properly established- Initiate and monitor on going as well as follow up stability.- Transfer projects at site level and liaises efficiently with involved functions (e.g. Development, Supply Chain, Production Unit, Quality Control, HS&E) and other sites. Show less

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  Eskayef pharmaceuticals ltd.

  May 2020 - May 2022

  -Design and conduct experiments for developing new product formulations.-Scale Up and characterize new product processes-Optimizes product and process to reduce costs or improve value to support.-Execute process improvements or development-Troubleshooting of problematic products (e.g. Weak point remediation)-Technology transfer and launches, liaise with technical developments for new products and align on the process validation approach. -Design and conduct experiments for developing new product formulations.-Scale Up and characterize new product processes-Optimizes product and process to reduce costs or improve value to support.-Execute process improvements or development-Troubleshooting of problematic products (e.g. Weak point remediation)-Technology transfer and launches, liaise with technical developments for new products and align on the process validation approach.

  • Senior Assistant Manager-Research and Development

    Jan 2022 - May 2022

  • Assistant Manager-Research and Development

    May 2020 - Dec 2021
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  Genvion corporation

  Aug 2022 - Jul 2023

  Quality assurance -sme( cleaning validation)

  •Coordination, Execution and Oversight of all aspects of Cleaning Validation Programs onsite for a large-scale pharmaceutical production facility as per CVMP.• Coordinate and execute the activities of CSV( Computer System Validation) with external consultants and service suppliers as per GAMP 5.• Implemented grouping and bracketing approach to reduce the work load and improve the quality.• Execution, Coordination and Oversight the qualification (IQ,OQ,PQ)and validation protocols and summary reports.• Execution of Oncology product process transfer like Olaparib, Paclitaxel, Pomalidomide, Lenalidomide etc.• Provide technical advice and guidance to manufacturing personnel to ensure the effective and timely troubleshooting of process and equipment.• Generating deviations notifications, Execute Deviation Investigations and Corrective Action and Preventive Action.• Provide support as a subject matter expert (SME) to various projects and initiatives as required by the management. Show less

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  Bausch health companies inc.

  Jul 2023 - now

  Validation specialist

  1. Responsible for the overall program coordination of process validation and cleaning validation activities, facilitate process validation and Cleaning Validation Team meetings, liaise with regulatory bodies and customers during audits.2. Prepare, review, and approve process and cleaning validation documentation including Validation master plan (VMP), Cleaning Validation Master Plan, validation procedures, protocols, reports and methods.3. Prepare control strategy, Quality Risk Assessment (QRA), Protocol and Report for Continued Process Verification (CPV)4. Coordinate analytical studies and cleaning procedure development and/or method development to ensure all key elements are incorporated and scientifically justified.5. Participate in process or cleaning related investigations and, where required, assist with development and implementation of corrective actions.6. Ensure compliance with good manufacturing practices (cGMP) and regulatory requirements in a manufacturing environment. Show less