Experience

Kyowa Kirin Co., Ltd.

• Japan
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Quality Assurance Specialist

  • Apr 2021 - Present

  ▦ Change control of API (small molecule and large molecule), packaging material (combination product, PFS) and facilities (biologics production facilities) ▦ Documentation for GMP compliance, GQP compliance ▦ Preparing Quality agreement with API manufacturer, intermediate manufacturer, Drug product manufacturer, exported countries ▦ Concluding specification with manufacturer (API manufacturer, CMO) ▦ Participate in periodic global product review meeting with Asia Pacific, Europe, US region ▦ Regulatory support for Japan, Asia Pacific, Europe and US area ▦ Act as a product responsible person for biologics and organize related project ▦ Act as a member of data integrity management team. ▦ Periodic consistency check (manufacturing and testing) of the marketing approval for drug license ▦ Control of quality event e.g., change control, deviation, CAPA in Kyowa Kirin e-QMS system Show less



Nipro Pharma Corporation

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Corporate Quality Assurance

  • Sep 2015 - Mar 2021

  ▦ Change management, devation control for APIs, excipients and packaging material ▦ Documentation for GMP compliance ▦ Performing self inspection for all Nipro pharma factories ▦ Manage the corrective and preventive action (CAPA) for the factory GMP issues ▦ Preparing GQP agreement as well as specification with manufacturer of APIs and intermediates ▦ Preparing Qualty agreement, Confidential agreement with the additives manufacturer ▦ Perform GMP audits for manufacturers of APIs, excipients and packaging material ▦ Answering the inquiries from Japanese regulatory authority (PMDA) regarding the changes issues. ▦ Management of the documents (DMF, LOA, manufacturer qualification) to support regulatory affairs group. ▦ Support to regulatory affairs group regarding the notice (like CTD application, Residual solvent control) from PMDA ▦ Control the production unit according to the approved system for drug lincence and product standard document ▦ Supplier management and change Control according to the Master Control system Show less



Yume Technology Co.,LTD.

• Staffing and Recruiting
• 1 - 100 Employee

• Engineer (Chemical)

  • Jun 2014 - Aug 2015

  ▦ Technical support for formulation development in oral pharmaceutical dosage forms ▦ Scale up process for oral disintegration tablet ▦ Manufacturing the granules for tablets using Granulation machines (MP-1 ,Powrex Corporation) and making tablets with Tableting machine (HATA Corporation) ▦ Evaluation the physical properties like disintegration test, dissolution test, friability test ▦ Stability studies of the new medicines （Analysis of the medicines stored in different storage conditions using HPLC,UV-Visible Spectrophotometer） ▦ Technical support to other researchers for smell reductions, increasing the dissolution rate for ODS tablet. Show less



Advantec Corporation

• Technical Support

  • Sep 2012 - May 2014

  Position: Technical Support (September 2012~) ▦ Analysis (qualitative, quantitative) of minerals, cements and construction materials by powder X-ray diffractometer (Rigaku, RINT 2500) ▦ Elemental analysis of minerals with X-ray fluorescence Spectrophotometer (Shimadzu, XRF-1800) ▦ Thermo gravimetric and calorimetric analysis of construction materials using TG-DTA (Rigaku, TG8120), DSC (Rigaku, model 8230) ▦ Material identification (mainly organic material) by FTIR spectrometer (JASCO IRT 5000) ▦ Elemental analysis (mainly heavy metal) by Atomic Absorption Spectrophotometer (Hitachi, Z-2710) ▦ Separation of ions and polar molecules with ion chromatography (DIONEX ICS-2100) ▦ Determine the particle size, shape of concrete material with SEM/EDS (Hitachi SU3500) ▦ Quantitative analysis of evolved gas by GC (Shimadzu- GC 2014 with TCD detector) ▦ Discussion with different research group regarding materials development. ▦ Customer supports through identifying the cause for claims. Show less



Rigaku

• Japan
• Appliances, Electrical, and Electronics Manufacturing
• 200 - 300 Employee

• Application Engineer & Application Scientist

  • Apr 2008 - Aug 2012

  Employer: Rigaku Corporation, Japan Position: Application engineer (April 2009-August 2012) Major Responsibility: ▦ Analysis of customer’s sample [powder(in general), semiconductor and electronic material, nanomaterials, pharmaceuticals, polymer, ceramics, metal etc.] using powder X-ray diffractometer (Rigaku XRD system like MiniflexⅡ, UltimaⅣ, TTR3, SmartLab, RINT RAPIDⅡ) ▦ To train the foreign service engineer on the fundamental and application of X-ray diffraction. . ▦ To support the customer regarding measurement software and application software. ▦ Trouble shootings for analysis and computer communication. ▦ Checking and repairing of printed circuit board ▦ Mechanical assembling of electric furnace , attachment, Scintillation counter, goniometer Position: Application Scientist (April 2008-March 2009) ▦ Analysis of customer’s samples with different XRD systems and making reports . ▦ Elemental analysis with X-ray fluorescence spectrometer (EDX-300). ▦ Performing different type of XRD applications like In-plane measurement, Micro-area, SAXS, Thin film, High temperature, preferred orientation, Residual stress and Pole figure measurement. ▦ Performing different type of analysis like Qualitative analysis, Quantitative analysis (Rietveld refinement), Crystal structure analysis, Particle and pore size analysis, Crystallinity analysis, Residual stress analysis, Pole figure analysis, Preferred orientation analysis, Thin film analysis (film thickness, density, roughness), retained austenite analysis etc. ▦ Crystal structure determination of organic molecules by Single crystal X-ray diffractometer (CCD-Saturn724, CCD-Mercury, RAPIDⅡ(curved IP), R-AXIS IV++ with IP) ▦ Thermal analysis with TG-DTA(TG8120), DSC(8230) system. ▦ Support to customers for the day to day problem for measurement and analysis. ▦ To train the customers on the fundamentals of X-ray diffraction and the applications. Show less



ACI Limited

• Bangladesh
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Product development and Quality assurance

  • Feb 1999 - Oct 2004

  Employer: ACI Limited, Bangladesh (Manufacturer of pharmaceuticals and others) Position: Product Development Officer Duration: February 1999 – January 2002 Major Responsibility: ▦ Formulation of pharmaceutical dosages form (Oral, topical) ▦ Trial batch production and stability study at different storage conditions (temperature, humidity) ▦ Analytical method development and method validation ▦ Process validation for new products ▦ Documentations according to GMP guidelines Position: Quality Assurance Officer Duration: February 2002 – September 2004 ▦ Analysis of raw and finished product [analytical instrument used are HPLC(WATERS), Potentiometric Titrator, UV-visible Spectrophotometer(SHIMADZU) etc.] ▦ Making SOPs of all laboratory instrument according to GLP guidelines. ▦ In process quality control of pharmaceutical products. ▦ Quantitative analysis of antibiotics (microbiological method) ▦ Documentation and calibration of laboratory equipment Professional Training: ▦ Trained on ISO 9001 (Quality management system) and ISO 14001 (environmental management system) at ACI Limited, Bangladesh (on March, 2000) ▦ Trained on GMP (Good manufacturing practice) and GLP (Good laboratory practice) at ACI Limited, Bangladesh (on April, 2000) Show less