Abdulla Al-Mamun (Kishor)

01.Dossier preparation, checking and submission according to CTD and eCTD 02. Implementation Quality Management System according to GMP guidelines 03. Conduct GMP, SOPs & TNA training with maintain proper records 04. Preparation Site Master File (SMF) according WHO guidelines and checking 05. Preparation Quality Manual and checking 06. To handle Change Control, Deviation, Market Compliant and CAPA 07. Preparation all validation protocol like analytical, process validation, cleaning validation method and HVAC system validation with checking it' report 08. To conduct internal audit and follow-up action 09. Preparation all kinds of SOPs and checking 10. To handle DGDA audit independently

01. To handle Inspection 02. Implementation Quality Management System 03. Source Validation 04. Vendor's Performance Rating 05. Conduct training cGMP, GLP according to Who, ICH and others guidelines 06. Preparation Site Master File (SMF) 07. Handle Deviation, Change Control, CAPA, Market Complaints & Product Recall 08. Preparation SOPs 09. Handle Quality Risk Management 10. Preparation Validation Protocol

01. Preparing and Checking of Analytical Method and Process Validation with Validation Protocol. 02. Able to prepare Site Master File (SMF) and Validation Master Plan (VMP) 03. Preparation and Checking of Stability Study Protocol and its SOP. 04. Able to handle Deviation and Quality Risk Management (QRM). 05. Handling of Internal Audit/Self Inspection and Prepare report. 06. To conduct On Job, GMP, GLP, GDP, GWP Training etc. 07. Able to handle Market Complaint, Product Recall, Change Control and OSS. 08. Able to Prepare Quality Manual, GMP Training Manual. 09. Able to handle Corrective Action and Prevention Action (CAPA). 10. Able to Prepare and Check SOP for QA Dept. & other concern area according to GMP guideline. 11. Able to prepare and Check BMR & BRP, STP & Specification for RM, PM and Finished Product. 12. Able to perform Calibration and Validation QC Machineries. 13. Issuing BMR, BPR, Logbook, following the respective SOPs. 14. Able to operate HPLC, UV-Vis Spectrophotometer and dissolution Test Apparatus and other instrument related to QC Department. 15. Performing Line Clearance/Start-Up and In Process Checks during manufacturing operations. 16. Participating in assigned Validation/Qualification activity as per approved protocol. 17. Able to Perform IPQA Checking and Batch Release Activities. 18. Participating of new packaging materials development activity.