Ahasanul kabir Shohan

• Handling of Vendor/Supplier Quality system (Vendor/Supplier/Services Qualification) for Raw material and Packaging material of products
• Review, release, and control of Product specifications (Raw material specification, Packaging specification, In-process specification, and Finished Product Specification) and Analytical Method Validation of products
• 1. Coordinate with RA team, R&D team and QC team to provide support and documents required for product development and for filing Product Variation in respective Regulatory Authority.
• Coordinate with stakeholders to file de-registration of products in Regulatory Authority as per relevant SOP.
• Managing Product Stability studies request and Product Variation request through BMR (Batch manufacturing records) issuance and batch release
• To track and ensure commitments submitted to SFDA (Saudi Food & Drug Authority) are achieved and to track Avalon’s commitments for performing stability studies of products
• Handling market complain
• Handling OOS
• Proficient in dossier review and implementation as per SFDA.
• Implementation and enforcing all aspects of QMS (Quality Management system) and document control process.
• To work cross functionally with key stakeholders (Production, Quality Control, Supply Chain, Engineering etc.) to ensure Quality consistency as per cGMP.
• To track of New product launch after SFDA (Saudi Food & Drug Authority) approval and communicate to key stakeholders (Production, Quality Control, Supply chain etc.) for implementations and operations.
• To track product packaging Artwork revision status and to contact responsible departments for implementing the change in product artwork.
• Management of Product list
• To maintain and handle Quality Agreements of the company.
• Manage Product licensing / renewal.
• Assisted with internal and external audits to confirm compliance with applicable laws and regulations.
• Improved operational efficiency by streamlining compliance processes and reducing redundancies.
• Facilitated communication between departments, ensuring timely updates on compliance changes and their impact on operations.
• Played a key role in the successful completion of regulatory audits, providing necessary documentation and addressing any concerns raised by auditors.
• Achieved regulatory compliance by developing and implementing effective policies and procedures.
• Maintained up-to-date knowledge of industry regulations, ensuring timely implementation of new rules and guidelines.
• Conducted periodic compliance audits and reviews to identify areas of improvement.
• Completed field checks to verify licenses and permits for various business.

1. Review, release, and control of Product specifications (Raw material specification, Packaging specification, In-process specification, and Finished Product Specification) and Analytical Method Validation of products.

2.1. To track and ensure commitments submitted to SFDA (Saudi Food & Drug Authority) are achieved and to track Avalon’s commitments for performing stability studies of products.

3.Handling of Vendor/Supplier Quality system (Vendor/Supplier/Services Qualification) for Raw material and Packaging material of products

4.Ensure Compliance to relevant standards (SFDA, GMP, GDP, ISO).

• Reviewed batch records to ensure complete traceability and compliance with industry standards and regulations.
• Improved overall product quality by conducting thorough IPQA inspections and identifying areas for improvement.
• Streamlined documentation processes, resulting in improved efficiency and accuracy of recordkeeping.
• Facilitated smooth transitions between product runs by coordinating closely with production teams on changeover activities, minimizing downtime due to setup adjustments required during this process.
• Supported process validation activities by providing timely feedback on product quality during various stages of production.
• Collaborated with cross-functional teams to identify root causes of quality issues and implement corrective actions.
• Acted as a trusted advisor on IPQA matters within the organization, providing guidance and support to colleagues seeking clarification on relevant policies, procedures, or best practices.
• Determined quality department standards, practices, and procedures.
• Tracked quality issues with external customers, suppliers, and internal plant operations.
• Specified quality requirements of raw materials with suppliers.
• Reported production malfunctions to managers and production supervisors.