K. M. Imrul Hasif Email & Phone Number

Tongi, Bd

Dhaka, Bangladesh

• Planning, organizing & executing the quality control tests for the incoming raw materials, finished products for tablets, capsules, liquids, suspensions, MDI & DPI, Sterile dry powder for vial injection & animal health products.• Gap Assessment & Coordination for CMO Projects, Communication with CMOs.• Communication with outside lab (FDA approved).• New source approval of raw material excipients and API, Prioritization of source.• Preparation of method Validation /Verification/Feasibility protocol.• Manage Out of Specification (OOS), Out of trend (OOT), Change controls, complaints, deviations, Investigation & Risk Assessment.• Analyzing QC activity monthly, prepare a productivity report.• Manage analytical method development and validation. Purchasing of new equipment for laboratory.• Monitoring the cleaning validation & manufacturing process validation.• Implementation of commercial real time stability & shelf life extension.• Updating and preparation QC related documents i.e. Specification, control directions. Preparation of SOPs (standard operating procedure) for Quality Control/ Quality Assurance activities and equipment's.

Dhaka, Bangladesh

• Lead and execute all analytical activities specially to design analytical method development and validation for Drug Products to phase using analytical techniques such as HPLC.• Responsible for pharmaceutical finished product release testing and stability testing.• Periodic review of SOP's and document reviews.

Dhaka, Bangladesh

• Responsible for testing of pharmaceutical raw materials and finished products to appropriate regulatory standards.• Operating HPLC, GC and other sophisticated instruments.• Responsible for calibration, maintenance and troubleshooting of laboratory instruments. • Following pharmacopoeia methods for testing pharmaceutical raw materials and finished products.

Master Of Science - Ms, Pharmaceutical Technology

Bachelor Of Pharmacy - Bpharm, B.Pharm, 3.723 Out Of 4.00