• Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. • Responsible for ensuring that all the quality activities during technology and/or analytical method transfer are timely completed meeting the Quality Standards.• Complete technical data package and add specific report, summarizing current product robustness from sending unit and complete the package during technology transfer.• To provide support for preparation of CMC document for the regional supported products during technology transfer.• Provide Quality Technical Leadership for process and regulatory deficiency issues.• Liaison between sites QA, commercial affiliates, MS&T and other groups as necessary.• To manage the creation of post-transfer Quality documentation.• Support Receiving Unit site in readiness and review of the receiving site quality documentation (manufacturing batch records, Critical Process Parameters report, validation and stability protocols, specifications, methods, training, material sourcing, equipment EHS, packaging, cleaning validation, transportation studies) as planned.• Implementing and maintaining policies, processes, procedures and plans that define the elements necessary to meet the Product Transfer QA objectives, as well as regulatory and business requirements.• Responsible for routine activities of Quality management for TPMs in Turkey, for delivering quality products through reliable supply chain.• Responsible for monitoring TPMs quality performance.• Responsible for reviewing of Quality Technical Agreements.• Contact for communication of TPM quality issues as needed.• QA support for investigations, trends, exceptions/deviations, complaints, stability, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control as needed

• Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. • Responsible for ensuring that all the quality activities during technology and/or analytical method transfer are timely completed meeting the Quality Standards.• Complete technical data package and add specific report, summarizing current product robustness from sending unit and complete the package during technology transfer.• To provide support for preparation of CMC document for the regional supported products during technology transfer.• Provide Quality Technical Leadership for process and regulatory deficiency issues.• Liaison between sites QA, commercial affiliates, MS&T and other groups as necessary.• To manage the creation of post-transfer Quality documentation.• Support Receiving Unit site in readiness and review of the receiving site quality documentation (manufacturing batch records, Critical Process Parameters report, validation and stability protocols, specifications, methods, training, material sourcing, equipment EHS, packaging, cleaning validation, transportation studies) as planned.• Implementing and maintaining policies, processes, procedures and plans that define the elements necessary to meet the Product Transfer QA objectives, as well as regulatory and business requirements.• Responsible for routine activities of Quality management for TPMs in Turkey, for delivering quality products through reliable supply chain.• Responsible for monitoring TPMs quality performance.• Responsible for reviewing of Quality Technical Agreements.• Contact for communication of TPM quality issues as needed.• QA support for investigations, trends, exceptions/deviations, complaints, stability, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control as needed.

• Managing the quality and compliance of products provided by third-party manufacturers and suppliers, monitoring their quality performances, identifying non-conformances, and ensuring the implementation of corrective actions,• Closely collaborating with TPM/suppliers to establish and maintain quality agreements that outline quality expectations and standards, and providing valuable support to improve their quality assurance processes,• Maintaining comprehensive records of audits, assessments, and compliance activities and preparing detailed reports and documentation for stakeholders,• Also, supporting the Turkiye localization project and due diligence activities, delivering high-quality documentation for Turkiye's regulatory submissions and variations, and maintaining the integrity of the TPM/Supplier Quality Assurance documentation system.

• Managed the GLIMS, Stability, and Finished Product teams to guarantee the stability and quality of products, and oversaw all aspects of stability testing, analysis, and reporting,• Implemented quality control processes to ensure stability testing adheres to industry standards and regulations, scheduled the analysis of finished products, and provided approval for release,• Maintained and updated the stability specifications and analysis methods, provided critical technical training such as GMP, DI, and SOP to the lab staff and ensured effective operation of the GLIMS platform,• Supported cleaning validation studies and decisions, ensured the verification of process validation protocols, and actively performed validation work in the laboratory, • Also, ensured the sustainability of management system documents in the Environment, Occupational Health, and Safety management system as an internal auditor, conducted audits related to GMP, and represented the organization throughout the ministry and other global audits.

• Ensured the seamless transfer and effective implementation of the GLIMS Project (Global Laboratory Information Management System) at Pfizer Turkiye,• Identified potential project risks and developed strategies to mitigate them, provided training and technical support to project admins, and facilitated communication and collaboration with employees abroad.***Integrated the GLIMS system in Istanbul, achieving the task 5% ahead of the targeted timeline and earned a promotion to Stability Section Head.

• Secured the quality, integrity, and regulatory compliance of raw materials utilized in quality control laboratories and oversaw adherence to GLP, GMP, and Environmental Occupational Health and Safety standards,• Received, and inspected notifications and complaints about raw materials, evaluated analysis to verify their conformity with established specifications, and presented comprehensive annual product evaluation and compliance reports to senior management,• Also, conducted training sessions to enhance the team's technical capabilities, executed critical Lean lab projects, prepared the annual budget, and represented the departments responsible for the ministry audits and Pfizer MSQA audits.

• Ensured that finished products met quality, safety, and compliance requirements, including adherence to GLP, GMP, and Environmental Occupational Health and Safety standards,• Analyzed, and interpreted analytical data to assess product quality and safety, maintained the laboratory equipment to ensure accuracy and reliability in testing and reported issues and deviations,• Also, prepared a wide variety of reports such as annual product evaluation reports, compliance reports, etc. provided technical training, and represented the departments responsible for the ministry audits and Pfizer MSQA audits.***Through the successful completion of the Standard Work project, achieved a remarkable 10% reduction in quality control approval times and were honored with the prestigious 'Mission Award'.***Led the Cleaning Validation project and oversaw the successful implementation of cleaning validation throughout the entire plant.

• Worked in close coordination with cross-functional teams to solve complex challenges; reported the analytical method validations and process validations for the developed products,• Compiled regulatory files for submission to the ministry, and prepared Standard Operating Procedures aligned with industry standards and regulations.