Ali Raza Irshad Hussain

Experience

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  CCL Pharmaceuticals

  Mar 2009 - Sept 2010

  Production Offier

  • Monitor and control all the activities regarding production (manufacturing + packaging)• Check and assure all activities done in production department under the specifications, standards, SOP’s, implemented in the production area• Prepare and review the batch manufacturing record and in time submission to Quality Assurance Dept.• Prepare and record the in house parameters like temperature, humidity, differential pressure, cleaning and mobbing and preparation of all machine log books• Prepare and implementation of weekly and monthly plans• Conducting staff training on GMP• Participate in preparation and development of new products• Held successful audits of GMP and inventory organized internally by management Show less

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  Siza International Pvt Limited.

  Oct 2010 - Dec 2011

  Production Officer

  Controlling, Handling , and Monitoring of all process and activities in SVP and LVP( 100,200 m L Glass bottle). Monitor and control all the activities regarding production (manufacturing + packaging)• Check and assure all activities done in production department under the specifications, standards, SOP’s, implemented in the production area• Prepare and review the batch manufacturing record and in time submission to Quality Assurance Dept.• Prepare and record the in house parameters like temperature, humidity, differential pressure, cleaning and mobbing and preparation of all machine log books• Prepare and implementation of weekly and monthly plans• Conducting staff training on GMP• Participate in preparation and development of new products• Held successful audits of GMP and inventory organized internally by management and Ministry of Health License renewal inspection. Attend the weekly meetings with reporting manager to report to owners regarding production progress and issues. Show less

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  BG para pharmaceuticals Dubai UAE

  May 2012 - Sept 2014

  Manager Production

  • Preparing & implementing operation and SOP’S describing processes• Ensuring complete in-process quality and continuous improvement in process capabilities• Ensuring quality across raw materials, work in progress, finished goods in various functional Departments as per cGMP certifications• Set implementation plan and schedules• Approve the instructions relating to production operations and to ensure their strict implementation• Ensure that the production records are evaluated and signed by an authorized person before they are sent to the Quality Control Department• Follow up daily production output and drive for continuous improvement• Review and control the batch production operation specifications and approve the master production insertions• Implement manufacturing processes that foster high quality with all approved regulatory requirements• Approve delivery of finished goods to warehouse• Authorize destruction of all types of waste for production• Conductance of training of workers and operators regarding work and environment• Revise monthly records of products(quantity and quality) and analyze variances against standard and monitors discrepancies• Set departmental expenses and capital requirements for new machine and equipments Show less

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  Medisal Pharmaceutical Industries L.L.C

  Sept 2014 - Dec 2016

  Regulatory Affairs Specialist

  • Act as authorized responsible person between company and regulatory authorities and maintain the link between them.• Registration and renewal of Pharmaceutical Industry License including GMP license, Manufacturing Site Certificate, Company Opening, and Chemical End User License. etc.• Collect, Prepare, and compile all the relevant data and documents regarding product dossier for submission like NS, 0.45%NS , 5% D , DNS ,10% D , 5% D & 0.45%NS, SWFI ,• Complete all the forms, Receipts, and Appointments submissions required for product registration.• Follow up the registration process by keep contact with concerned authorities.• Update the other department of company regarding ongoing changes in laws and regulations.• Manage the work on time for registration and approval of products. Show less

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  Medisal Pharmaceutical Industries L.L.C

  Sept 2014 - Sept 2015

  Regulatory Affairs and acting Production Manager

  A link between company and regulatory bodies.Preparation, collection, compilation and submission of all the documents regarding drug registration.preparation of all the forms from MOH UAE and arrangement of appointment required for registration.Controlling, Monitoring all production activities as per GMP and in house SOP's.

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  Genpharm Services

  Dec 2016 - May 2017

  Regulatory Affairs Assiciate

  Responsible for the timely completion of regulatory projects and submission of documentation, both internal and external.Perform Regulatory Affairs activities in defining regulatory processes and orientation for the distribution operations in the region consistent with business strategies.1.Prepare the submission file for the MENA region, ensuring compliance with local/regional health authorities.2.Monitor regulatory activities in individual countries at each stage, including submissions and expiry dates of registration certificates.3.Maintain existing internal databases, including Regional Requirement Tracker, Individual Country and Business Regulatory Trackers, and develop an efficient record-keeping tool.4.Support all registration and tender requests by coordinating the administrative part through applicable channels.5.Develop and maintain current regulatory knowledge in all countries that GENPHARM is operating in. Show less

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  Well Pharma Medical Solutions

  Feb 2018 - May 2019

  Regulatory Affairs and Quality Assurance Manager
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  ADCANPharma

  Jun 2019 - Aug 2022

  Regulatory Section Head
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  Microsynergy Pharmaceuticals FZCO Dubai

  Aug 2022 - now

  Regulatory Affairs Manager