S M ISHAQU FARHAN

Experience

• 

  Nuvista Pharma Limited

  Nov 2012 - Nov 2012

  Inplant training
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  NIPA Pharmaceuticals Ltd

  Feb 2013 - Aug 2013

  Officer, Quality control

  1. Sampling of raw materials, packaging materials and finished product.2. Analysis of raw materials and finished products.3. Preparation of QC/QA departmental SOPs.4. In Process Checking during manufacturing. 5. To prepare stability data of different product.6. Preparation of certificate of analysis for export products.

• 

  Delta Pharma Limited

  Oct 2014 - Mar 2016

  Executive, Quality Assurance

  Job Responsibility:1. Dossier preparation and review as per country specific guideline/CTD guideline. 2. Provide specimen sample for buyers.3. Preparation of certificate of analysis for export purpose.4. To prepare stability data of different product for export.5. To check packing lists for export.6. Responsible for measurement of new packaging materials of exported items.7. Handling of Annexure for export.8. Ensure the quality of export items.

• 

  Beacon Pharmaceuticals Limited

  Mar 2016 - Dec 2021

  1. Preparation, review and Submission of Dossier as per CTD/ACTD format or any other country specific dossier.2. Review of documents and data generation for ensuring quick response to queries received from the agency to expedite the approval process.3. Co-ordinate with others department, factory & International Regulatory Authorities to resolve queries/deficiencies. And reply to regulatory agencies regarding query/deficiency.4. Relevant change control approval (IRA end) & Keep tracking of changing of any relevant documents of Dossier of any products (through change control) & as well as upgradation timely.5. To keep track of changing of regulatory legislation and communicating to respective departments.6. Preparation of technical documents required for product registration purpose in export (if required).7. Checking of Artwork & PMS for final approval.8. Control of all regulatory relevant documents like registration Certificates, GMP certificates.9. Conduct/Participate internal/external Audit.10. Archiving of all submitted Dossier & all registered Dossier11. Any other responsibilities given by the management time to time. Show less 1. Preparation of Dossier (CTD, ACTD & Country Specific) for product registration in different Countries.2. Review of documents and data generation for ensuring quick response to queries received from the agency to expedite the approval process.3. Maintain tracking of export documents that provided to regulatory authorities. 4. Review of batch documents, QC documents before release of General, Biotech and Oncology Products5. Release of bulk products for intermediate stages in all dosage form for both general and Oncology existing products through current release procedure6. Coordination of customer complaint activities, investigate to identify the root cause when required & providing feedback to the complainant and ultimate objective to reduce market complaint. 7. Preparation and upgradation of SOPs relevant to Quality Operations. 8. Performing IPC activities as required and established of cGMP as per SOPs. 9. Coordinate packaging materials development activities (from artwork checking to final packaging design approval). Like control of tracking number of all packaging materials, supersede the old version of packaging materials and other activities.10. Any other responsibilities given by the management time to time. Show less 1. Preparation of Dossier (CTD, ACTD & Country Specific) for product registration in different Countries.2. Review of documents and data generation for ensuring quick response to queries received from the agency to expedite the approval process.3. Maintain tracking of export documents that provided to regulatory authorities. 4. Review of batch documents, QC documents before release of General, Biotech and Oncology Products5. Preparation and upgradation of SOPs relevant to Quality Operations. 6. Performing IPC activities as required and established of cGMP as per SOPs. 7. Coordinate packaging materials development activities (from artwork checking to final packaging design approval). Like control of tracking number of all packaging materials, supersede the old version of packaging materials and other activities.9. Any other responsibilities given by the management time to time. Show less

  • Jr. Asst. Manager, International Regulatory Affairs

    Jan 2020 - Dec 2021

  • Senior Executive, Quality Compliance

    Jan 2017 - Dec 2019

  • Executive, Quality Compliance

    Mar 2016 - Dec 2016
• 

  Beacon Medicare Limited

  Jan 2022 - Feb 2025

  Assistant Manager, International Regulatory Affairs

  1. Preparation, review and Submission of Dossier as per CTD/ACTD format or any other country specific dossier.2. Review of documents and data generation for ensuring quick response to queries received from the agency to expedite the approval process.3. Co-ordinate with others department, factory & International Regulatory Authorities to resolve queries/deficiencies. And reply to regulatory agencies regarding query/deficiency.4. Relevant change control approval (IRA end) & Keep tracking of changing of any relevant documents of Dossier of any products (through change control) & as well as upgradation timely.5. To keep track of changing of regulatory legislation and communicating to respective departments.6. Preparation of technical documents required for product registration purpose in export (if required).7. Checking of Artwork & PMS for final approval.8. Control of all regulatory relevant documents like registration Certificates, GMP certificates.9. Conduct/Participate internal/external Audit.10. Co-ordinate to Archiving of all submitted Dossier & all registered Dossier11. Any other responsibilities given by the management time to time. Show less