Quality Control Raw Materials

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MAHFUZ AHMED

**** **** ***** **, ******. TX 75062 ê +1-773-***-**** ê

*************@*****.*** ê ************@*****.*** ê www.linkedin.com/in/mahfuz-ahmed-qc-chemist Expert quality control person with analytical, leadership, management and operational skills. Having more than 11+ years of analytical laboratory experience in a US-FDA approved pharmaceutical industry. Strong analytical abilities in wet chemistry, strategic planning skills to develop effective QC procedures and efficient solutions to address production issues, improve operational efficiency, and reduce overall project costs. Following a planned career break, fully prepared to contribute deep expertise in analytical chemistry within a regulated laboratory environment.

* Quantitative and qualitative chemical analysis * Equipment maintenance and qualification

* Raw materials, In-process control and finished products * SAP software and Lab-ware software (LIMS)

* Sampling of raw materials and wet chemistry analysis * Analytical method transfer and stability studies

* Analytical data review and batch release * OOS, OOT, LIR, deviations and CAPA

*. Data Integrity, ALCOA+ principle and 21 CFR, part-11 * cGMP, GLP and lab safety regulations.

* Test method and USP/BP/EP pharmacopeias * UV, FTIR, AAS, TOC and Karl-Fischer titration

* SOP development and adherence * ICH, WHO and FDA guidelines

* Chromatography (HPLC. GC) * Empower, Chromeleon and Chem-station CDS Business System Analyst April 2025 to present

Debug LLC Chicago, IL, USA

• Collaborated with stakeholders to define business processes, authored system requirements, and supported development teams with user stories and acceptance criteria. Quality Control, In-charge January 2021 to September 2022 Square Pharmaceuticals Kenya EPZ Ltd. Machakos, Kenya

• Managed and directed the Quality Control Laboratory to ensure lab testing provide the highest quality analytical support for manufacturing while ensuring compliance with protocols, SOPs, cGMP and safety regulations.

• Successfully conducted analysis and supported the release of process validation batches at all stages, including raw materials, packaging materials, in-process samples, finished products, and stability samples.

• Collaborated with formulation and QC teams to ensure seamless transition of products through development stages and assisted in the development of a formulation and conducted in-process control testing to monitor critical quality attributes during development.

Professional Summery

Professional Skills

Professional Experience

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• Performed and supervised the calibration activity of laboratory instruments like HPLC, GC, TOC, Karl- Fischer, Dissolution Tester, UV-Vis spectrophotometer, AAS, FTIR, Muffle Furnace, Stability Chamber, analytical balances, LOD oven, pH meter etc.

Senior Executive, Quality Control January 2016 to December 2020 Square Pharmaceuticals PLC. Dhaka Unit, Bangladesh

• Performed routine and non-routine chemical testing of commercial, validation, and stability samples using HPLC, GC, UV/Vis, and FTIR, ensuring compliance with USP, cGMP, and FDA regulations

• Led a team of 15 analysts in pharmaceutical QC Laboratory, ensuring full compliance with SOPs, cGMP guidelines, and FDA regulatory standards. Strengthened data integrity by 100% and reduced production issues by 80% through enhanced oversight, training, and process optimization.

• Managed and investigated different types of QMS activities like OOS, laboratory incidents, OOT, deviations as well as implemented associated CAPAs.

• Reviewed quantitative and qualitative analytical data of raw materials and bulk products.

• Utilized SAP software to manage quality control data, generate Certificates of Analysis, and facilitate the release of raw materials, packaging materials, and finished product batches, ensuring accurate documentation and on-time availability for production and distribution.

• Prepared and reviewed specifications and test methods for raw materials, packaging materials, and finished products in accordance with USP/BP/EP pharmacopeias, manufacturer guidelines, and validation reports. Executive, Quality Control April 2011 to December 2015 Square Pharmaceuticals PLC. Dhaka Unit, Bangladesh

• Sampling of in-coming raw and packaging materials for quality control testing.

• Conducted the quantitative and qualitative chemical analysis of test samples (finished product, In-process materials, raw materials and water) in HPLC, UV, FTIR, Dissolution tester, pH Meter, Conductivity Meter, Analytical Balance, Muffle Furnace, and other analytical equipment. M.Sc. (Master of Science): Chemistry 2011

Shahjalal University of Science and Technology Sylhet, Bangladesh B.Sc. (Bachelor of Science): Chemistry 2009

Shahjalal University of Science and Technology Sylhet, Bangladesh Accomplished and supported successful regulatory audits conducted by global health authorities, including: US-FDA, WHO, UK-MHRA, TGA (Australia), MCC (South Africa), PPB (Kenya), and DGDA (Bangladesh), etc. Accomplishments

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Education

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