CV Profile No.33529

Experience in the following industries :

• Chemistry, petrochemistry, raw materials, mining
• Food-processing industry
• Pharmaceutical industry

Professional experience

• Officer in Quality Control Department
• Glenmark Pharmaceutical
• 12.2011 - 04.2014
• Analysis and sampling of Raw Material, Finish Goods and stability sample Analysis and sampling of Packing Material Analysis of Stability Samples. Calibration of Instrument. Review of Stability, Raw Material and GLP Data. Analysis of in process and finished Product samples. Preparation of Analytical Reports as per GLP. Preparation of Working Standards. Handling of following Instruments: Operation and Calibration of High Performance Liquid Chromatography. Operation and Calibration of Gas chromatography. Operation and Calibration of Atomic Absorption Spectrophotometer. Operation and calibration of U.V Spectrophotometer. Operation and calibration of FTIR Operation and calibration of Dissolution. Operation and calibration of viscometer Operation and calibration of Auto-Titrator. Operation and calibration of Karl fisher Operation and calibration of DT Apparatus. Operation and calibration of Friability Test Apparatus Operation and calibration of Refractometer. Operation and calibration of Melting Point Apparatus.

• Executive
• Nectar life Science
• 06.2014 - 06.2016
• Preparation of Stability Protocols as per ICH Guidelines or any country specific requirements. Preparation of Stability schedule as per Stability Protocols for Stability products. Management of Stability chambers and monitoring their temperature and Humidity records. Preparation of Working Standards. Preparation of Stability Summary Reports for tabulated and graphical presentations. Review of Stability data for accuracy and compliance. Review of calibration and Qualification documents for their accuracy and completeness. Handling of HPLC and GC Column. Handling of Capex. Analysis of Stability samples (Tablets, Capsule, and Syrups) Analysis of in process and finished Product samples. Preparation of Analytical Reports as per GLP.

• Working as section Head
• Zifam Pyrex Myanmar Co. Ltd.
• Since 06.2016
• Handling of change control, OOS, OOT, Deviations & investigations (Quality Management System) QMS. Review of Analytical Method Validation Protocol, Reports and documents for accuracy and Compliance. Resource management, planning, monitoring and control of manpower, instruments and equipment’s usage, to accomplish workload requirements. To Coordinate with QA and Regulatory Affair Department for data filing and submitting. To participate in internal audits and regulatory inspections at the site. To prepare Analytical Method Validation Protocols. To update documents as per pharmacopoeia changes and change in regulatory guidelines. Preparation, training of SOPs and execution of activities to ensure compliance as per standard operating procedures. To prepare the URS for instruments. To prepare STP, GTP of Products as per regulatory requirements. To develop internal training modules for staff and workers to enhance their abilities and to update them w.r.t. latest requirements of GLP and GMP. To provide training to the analysts for operation of lab Instruments and trouble shooting.