Pharmaceutical Quality Control & Analytical Sciences
Assistant Manager, Quality Control (Oncology QC) — Healthcare Pharmaceuticals Limited
Profile
Md. Nazrul Islam is a pharmaceutical Quality Control and analytical-sciences specialist with about 16 years of industry experience spanning General Solid, Cephalosporin, Ophthalmic, MDI, DPI, General Sterile, Oncology Solid, and Oncology Sterile dosage forms. He currently serves as Assistant Manager, Quality Control (Oncology QC) at Healthcare Pharmaceuticals Limited, Rajendrapur — leading QC operations for testing and release of starting materials, finished products, and packaging materials, including toll-manufactured products for Beximco and Aristopharma.
His technical expertise covers analytical method validation and transfer (ICH/USP), stability studies (ICH), instrument qualification (URS, DQ, IQ, OQ, PQ), Out-of-Specification (OOS) investigation, deviation and quality risk assessment, CAPA, and the establishment of GLP- and data-integrity-compliant laboratories aligned with USFDA (21 CFR), EU (Eudralex), PIC/S, and TGA guidelines. He has served as Lab Solution Manager for the Shimadzu CDS System, has hands-on experience with Waters Empower 3 and Shimadzu LabSolutions CS, and works routinely with XRD, HPLC, GC, TLC, UV-Vis and IR spectroscopy, AAS, KF, dissolution tester, polarimeter, viscometer, DSC, surface area analyzer, polarized microscope, and Malvern particle-size analyzer. He has prepared QC laboratories for and faced audits from TGA, NPRA, ISO, and EU-GMP, with active preparation underway for upcoming USFDA, EU, and ANVISA inspections.
He holds an MSc in Inorganic Chemistry (Department of Chemistry, University of Rajshahi) and a BSc (Honours) in Chemistry from the same institution. As a member of the Joint Advisory Team (JAT) of the Kekuleon Research and Training Center (KRTC), he contributes regulatory- and audit-grade insights to curriculum design, instrument training, and laboratory-quality practice — helping align KRTC's analytical-chemistry programmes with the standards of internationally regulated pharmaceutical manufacturing.
Appointments
Kekuleon Research and Training Center (KRTC)
Advising on curriculum design, instrument training, and laboratory-quality practice — particularly in pharmaceutical QC, analytical method validation, stability science, and regulatory audit readiness.
Healthcare Pharmaceuticals Limited, Rajendrapur, Gazipur
Leads Oncology QC operations — testing and release of raw, intermediate, and finished products including toll-manufactured products for Beximco and Aristopharma; Lab Solution Manager of the Shimadzu CDS System; designs lab specifications and documentation to comply with USFDA, EU (21 CFR, Eudralex, PIC/S) and ANVISA guidelines; manages analytical method validation/verification, process validation, instrument qualification, stability studies, OOS investigations, deviation and quality risk assessment, CAPA, and audit preparation.
Healthcare Pharmaceuticals Limited, Rajendrapur, Gazipur
Acting in-charge of Oncology QC — laboratory setup of Specialised Oncology QC, Chromatographic Data System establishment, OOS investigation framework, employee training, and EU/USFDA audit readiness.
Healthcare Pharmaceuticals Limited, Rajendrapur, Gazipur
Quality Control readiness for TGA and NPRA audits, finished-product analysis monitoring, instrument calibration, OOS handling, follow-up stability sample management, SOP/STP preparation, training execution, and management of HPLC columns and reference/working standards.
Healthcare Pharmaceuticals Limited, Rajendrapur, Gazipur
Regulatory-audit readiness, finished-product analysis monitoring, biotech product analysis (SE-HPLC and RP-HPLC), MDI/DPI product analysis, SOP/STP preparation, qualification documentation, and laboratory troubleshooting.
Healthcare Pharmaceuticals Limited, Rajendrapur, Gazipur
Cephalosporin solid finished-product analysis, calibration of HPLC, UV-Vis spectrophotometer and dissolution tester, SOP/STP and qualification document preparation, and laboratory troubleshooting.
Supreme Pharmaceuticals Limited, Palashbari, Ashulia, Dhaka
Raw-material sampling and analysis, finished-product analysis, in-process checks, line clearance, batch document compilation, and product stability studies.
Recognition