Danish Saiyad

• Led QA team in streamlining implementation of quality management system (PQS), enhancing compliance and operational efficiency.
• Led Computer System Validation team to ensure software compliance with EU Annex 11 requirements.
• Executed Change Control, Deviation, Incident, CAPA, and other QMS-related SOPs to ensure rigorous quality standards.
• Implementation of continuous process verification through three sigma approach and process capability index.
• Managed country audits and third-party vendor audits, ensuring adherence to regulatory requirements.
• Evaluated third-party technology transfer documentation, resulting in approval of manufacturing documents for efficient product execution.
• Evaluated and approved the software validation processes in lab environments and pharma settings.
• Implementation of e-logbooks, e-QMS, document management system in QA as well in cross-functional department.
• EU GMP, PIC/S and WHO GMP compliant company, manufacturing OTC and prescription products meant for export to Regulated Countries and Semi regulated countries.

Led QA team to implement and maintain Quality System for improved compliance and control.

• Implemented Change Control, Deviation, Incident, CAPA, and other QMS-related SOPs to ensure regulatory adherence.
• Trained all subordinate staff on GMP requirements and confirmed adherence by each staff member.
• Initiated quality improvement projects that elevated product standards and compliance.
• Aan Lifescience is a WHO GMP compliant company, manufacturing Beta & Cefa products (Clav products) and prescription product meant for Domestic market & Export Market.

• Executed Stability Study SOP, ensuring adherence to regulatory standards for product stability.
• Coordinated with Validation and Calibration Agency to ensure successful HVAC and Compressed Air Validations.
• Review of process validation protocol and execution of Process Validation
• Review of executed batch manufacturing records.
• Responsible for impact assessment of Change Control, Deviation and Incident.
• Executed training sessions, enhancing staff compliance with established training schedule.
• Manufactured OTC and prescription products for export to various countries, including Uganda, Tanzania, and Kenya.

• Review of dossier documents like Stability study data, Product Development Report, Finish Product Specification & Method of Analysis, Raw Material Specification, and Packing Material Specification.
• Compiled standardized technical documents for creation of CTD, ensuring compliance with regulatory requirements.
• Coordinated with manufacturers to gather essential dossier documents, facilitating regulatory compliance process.
• Prepared comprehensive dossier that met regulatory standards, supporting successful product approval.
• Review of executed batch manufacturing records.
• Preparation of Application for Loan Licence, COPP, Free Sale Certificate & Manufacturing Licence.
• BioMatrix is an export-oriented company, manufacturing on Loan Licence OTC and prescription product meant for export to countries like Congo, Mozambique, Uzbekistan, Georgia and Malawi.

• Prepared SOPs and process validation documents to ensure compliance with regulatory standards.
• Reviewed draft master formula records, batch manufacturing records, and batch packing records for accuracy and completeness.
• Assessed executed batch manufacturing records to verify adherence to established protocols.
• Manufactured OTC and prescription products for export to various African countries.

• Handled live influenza virus in inoculated embryonated chicken eggs to support vaccine development.
• Monitored environmental viable counts in production area during and after cleaning to ensure compliance with safety standards.
• Ensured a sterile environment was preserved during production processes to prevent contamination.
• Completed batch documentation accurately to maintain compliance with regulatory requirements.
• Completing task in accordance with cGMP and within CSL’s Quality Management System.
• CSL group is manufacturer and developer of vaccines and plasma protein biotherapies with major facilities in Australia, Germany, Switzerland and the US. CSL manufacture and provide influenza vaccine globally.