Ifteajul Kafi
Horsham
Summary
Enthusiastic and detail-oriented professional with extensive experience in Quality Assurance and Regulatory Affairs, dedicated to ensuring compliance and excellence. Strong passion for enhancing operational efficiency through effective document control and quality analysis drives a commitment to contribute valuable skills to an esteemed team. Aiming to achieve remarkable results while fostering a culture of continuous improvement in quality assurance, ready to support organizational goals with a proactive approach.
Overview
14
14
years of professional experience
Work History
Quality Assurance Document Control Associate
Catalent Pharma Solutions
02.2022 - Current
- Reviewed and approved batch records to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
- Attended scheduling meetings when needed.
- Conducted risk assessments and implemented mitigation strategies for batch release processes.
- Participated in internal audit and inspection.
- Investigated and resolved issues or deviations related to batch release.
- Facilitated investigations and assisted in identifying appropriate corrective and preventing actions (CAPAs).
- Communicated with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation.
- Ensured compliance with regulatory requirements and company standards through meticulous oversight of the batch disposition process within JDE inventory management system.
- Implemented tracking methods for document revisions, enhancing retrieval efficiency and accuracy.
Quality Assurance Analyst II
Johnson & Johnson
08.2021 - 02.2022
- Performed daily ‘Shop Floor’ QA support to bulk manufacturing and packaging lines.
- Performed leadership support to QA Shop Floor activities including communication of quality events to management.
- Performed electronic Batch Record Review, Cleaning records review and Bulk material releases within Systems, Applications and Products in Data Processing (SAP).
- Performed GMP walk through audit-shop floor audit is completed per GMP requirement.
- Collaborated with cross-functional teams to identify and resolve defects, enhancing overall product reliability.
Executive Regulatory Affairs, R&D Department
Square Pharmaceuticals Ltd
08.2015 - 11.2019
- Developed SOPs in accordance with the organizational practices and compliance.
- Prepared of documentation for regulatory submissions including CTD to the regulatory agencies.
- Interfaced with other departments (Quality Control, Quality Assurance, Production/ Manufacturing) to coordinate collection of information for implementation in regulatory submissions.
- Experienced in R&D labs, executing studies, establishing parameters, developing evidence-based methods.
- Performed a variety of routine to complex sample preparation, analysis and testing supporting product development.
- Performed analytical testing on commercial and technical service batches using High Performance Liquid (HPLC), UV/Vis Spectroscopy, FTIR Spectroscopy, pH meter, Osmometer, Liquid Particle Counter.
Executive Quality Assurance, Quality Assurance Department
The ACME Laboratories Ltd
11.2014 - 06.2015
- Collaborated with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently.
- Performed In-Process Control in the production floor during manufacturing of pharmaceutical products.
- Performed on the floor QA coverage during production activities such as label check, cleaning, and other activities in accordance with GMP.
- Reviewed of the batch records and other documents to enable final drug product release certifying batch as GMP compliant.
- Led cross-functional teams to enhance laboratory operational efficiency and streamline workflows.
Executive Quality Assurance, Quality Assurance Department
Popular Pharmaceuticals Ltd
02.2012 - 11.2014
- Performed GMP and SOP implementation activities.
- Monitored the manufacturing process and performed In-Process Control in the production floor during manufacturing of pharmaceutical products.
- Reviewed of the batch records, Certificate of Analysis, and other documents to enable final drug product release certifying batch as GMP compliant.
- Reviewed documentation for accuracy, completeness, and compliance with GMPs.
- Developed and implemented strategic initiatives to improve product quality and compliance standards.
- Analyzed operational data to identify trends, driving continuous improvement in processes and outcomes.
- Mentored junior staff on best practices in laboratory procedures and safety protocols.
Education
MS in Pharmaceutical Sciences - Pharmaceutical Sciences
Thomas Jefferson University
PA, USA05.2025
Master of Pharmacy - Pharmacy
University of Development Alternative
Bangladesh05.2011
Bachelor of Pharmacy - Pharmacy
University of Development Alternative
Bangladesh10.2009
Skills
- High Performance Liquid (HPLC), UV/Vis Spectroscopy, FTIR Spectroscopy, Cell culture on laboratory, Electronic Batch Record Review including batch disposition
- Technology: Applications and Products in Data Processing (SAP) JDE inventory management system Laboratory Information Management System (LIMS) Electronic Document Management System (EDMS) software Microsoft Office
Websites
Timeline
Quality Assurance Document Control Associate
Catalent Pharma Solutions
02.2022 - Current
Quality Assurance Analyst II
Johnson & Johnson
08.2021 - 02.2022
Executive Regulatory Affairs, R&D Department
Square Pharmaceuticals Ltd
08.2015 - 11.2019
Executive Quality Assurance, Quality Assurance Department
The ACME Laboratories Ltd
11.2014 - 06.2015
Executive Quality Assurance, Quality Assurance Department
Popular Pharmaceuticals Ltd
02.2012 - 11.2014
Master of Pharmacy - Pharmacy
University of Development Alternative
Bachelor of Pharmacy - Pharmacy
University of Development Alternative
MS in Pharmaceutical Sciences - Pharmaceutical Sciences
Thomas Jefferson University
Professional Presentation
(2025, May) | Impact of Natural Compounds on several Cancer at Jefferson Alumni Hall, Philadelphia, PA, USA.