Md. Zakaria Faruki

Experience

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  The White Horse Pharmaceuticals Ltd.

  Jan 2008 - Jan 2011

  The White Horse Pharmaceuticals Ltd. (WHPL) is a modern plant that fully complies with cGMP-WHO requirements. A new state of the art Facility world class Pharmaceutical plant which is 4.5 Acres land. All the Facilities and equipment have been designed, built & procure to ensure international certification.

  • Executive, QA (Export Wing)

    Feb 2008 - Jan 2011

  • Executive, International Marketing

    Jan 2008 - Feb 2009
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  Healthcare Pharmaceuticals Limited

  Jan 2011 - Jun 2016

  Senior Executive, Quality Assurance (International Regulatory Affairs)

  • To prepare & review the Int'l Std. Registration Dossier for the Pharmaceuticals Products according to the Ministry of Health for the required countries. Carry out Export Documentation, [Dossier preparation CTD, ACTD, CIS, MCC, GCC & Non regulatory format (Kenya, Philippines, Malaysia, Vietnam, Ivory Coastm, Cambodia, Cameroon, Uzbekistan, Kazakhstan, Kirgizstan, Tazakistan, South Africa (MCC), Belarus, Jordan, Zimbabwe, Dominican republic, Mauritania, Tanzania, Ghana, Sri-lanka, Myanmar, Bhutan, kingdom of Bahrain and West Africa)].• Expert on Quality Part, Critical regulatory Part, Pharmacological, Clinical, Non-Clinical Pharmacological & Toxicological Part of Export Documents of The Regulatory Countries.• Frequently able to handle critical & technical Queries of Technical part like Bioequivalent Study, DMF & In-house queries.• Carryout regulatory documents for Drug Administration of Bangladesh and Abroad and feedback Market Compliance. • To conduct Site Master File (SMF), Validation Master File (VMF) Cleaning validation and APR.• To prepare Quality System Dossier (QSD) & Technology Transfer as part of DRA & Tech-transfer according to regulatory guidelines. Show less

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  Orion Pharma Ltd

  Jun 2016 - Jan 2021

  1) About 12 years of experience at Quality Assurance Department and Global Regulatory Compliance.2) Follow up Global Regulatory Compliance Related Activities of the Pharmaceutical Finished Product in the all Exporting Region.3) Review the Export Registration Documents as per the requirements of ICH CTD, Nees CTD, eCTD, ACTD, MCC, CIS, GCC, ANVISA and all other Regulated Market.4) Cooperate the Team Members to accelerate routine assignment for exploring the Products Globally. 5) Handling the export correspondences for keeping liaison with different departments along with International Marketing Department. Show less • Expert in preparation & reviewing the International Standard Registration Dossier of the Pharmaceuticals Products for Export purpose such as far ICH CTD, ACTD, GCC, MCC, CIS, LDCs & Country specific general formats in globally as per the demand of International Marketing Department within the stipulated time line.• Supervise team member to accelerate routine work like registration documentation, analytical & development activities to ensure monthly target for exploring the business in the global market.• Handling all types of export correspondences on behalf of technical team keeping liaison with different departments along with International Marketing Department.• Expert on Quality Part, Critical regulatory Part, Pharmacological, Clinical & Non-Clinical Part of Export Documents of the Regulatory Countries.• Frequently able to handle critical & technical Queries (NOD) of respective regulatory body/MOH/FDA & Investigate gap of DMF.• Maintaining foreign regulatory affairs related documents & synchronize with quality parameters.• Conduct Validation Related documentation & Stability Studies of FPP as per Climatic Zone.• Familiar with requirements of Bio-equivalence & in-vitro dissolution study for ANDA submissions.• Expertise in Product Development, Process Development, Process Optimization, Process Scale-up, Process Validation and Technology Transfer.• In process Control & Quality Assurance documentation.• Preparing necessary documents for exhibit batches (Master Formula Card, Stability Protocol, checking of validation protocols, Bio study protocols, Preparation of Product Development Reports etc.) • Literature survey, Patent search, Preformulation study, incompatibility study, Market evaluation and process development for dosage forms like Solid (immediate , Modified release), Injectables, Liquids, Semisolids, Ophthalmic preparation etc. Show less

  • In-charge, QA (Tejgaon Plant)

    Jul 2019 - Jan 2021

  • Assistant Manager, Quality Assurance Department

    Jan 2018 - Jun 2019

  • Assistant Manager, Global Regulatory Compliance

    Jun 2016 - Dec 2018
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  Lambert Academic Publishing

  Sept 2017 - now

  Book Author

  1st Book Link: https://www.amazon.com/Solubility-Enhancement-…/…/620202433X2nd Book Link: https://www.eurobuch.com/buch/isbn/6139864380.html3rd Book Link: https://www.morebooks.shop/…/phytoch…/isbn/978-3-659-62447-6

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  Prime Pharmaceuticals Ltd.

  Feb 2021 - Mar 2022

  Manager & Head of Quality

  • To ensure product quality by establishing the Quality Management System and implementing Good Manufacturing Practices in the manufacturing plant & distribution. Providing leadership and direction to the QA, QC & PD Team. Ensuring that the all the departments are staffed and equipped to effectively carry out the service required as per the cGMP compliance.• Responsible for planning and executing strategies to meet the objectives of producing required volume of products within acceptable quality standard by the innovative mixture of Man-Machine-Materials and Method as well as coordinates in the continuous improvement of existing and development of new products.• Responsible for ensuring product quality by establishing the Quality Management System and implementing Good Manufacturing Practices in the plant as a Quality Head. Show less

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  Silva Pharmaceuticals Limited

  Mar 2022 - now

  Manager & Head of Quality Assurance

  Responsible for overall Quality functions of Pharmaceuticals Manufacturing Site. Ensure product quality by establishing the Quality Management System (QMS) and implementing Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDocP) in the Manufacturing Plant & Distribution. Subsequently providing leadership and direction to the QA, QC & Export teams respectively. Also confirming that the all the Departments are staffed and equipped to effectively carry out the service required as per the cGMP compliance. Show less