Marikumar M Email & Phone Number

 A good understanding of Quality control & Quality Assurance, cGMP and GxP requirements of the pharmaceutical industry, customer and internal auditing. Reviewing audit compliance reports including deviations, change requests and regulatory data Responsible for self-inspection and data integrity audit of the various departments Responsible for the review of Invalid data, OOS, OOT and Laboratory incidents in LIMS & Track wiseand approval of stability protocols and reports. Review and Approval of Analytical Method Verification/Validation & Analytical method Transfer protocols and Reports. Responsible for periodic review of various instruments and software’s in Quality control laboratory.  Responsible for the Review and Approval of Specification, STP, Worksheet & COA for Raw material, packing material, In-process, stability and Finished product in LIMS & SAP Responsible for the Preparation, Review and approval of SOPs Related to Quality assurance and Quality Control departments Expertise in Analysis of API and OSD forms Raw materials, packing material, intermediates, Stability samples by using HPLC, PSD,GC,UV,IR,KF, Alpine, Polarimter,Viscometer, Refractometer.

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  Vellore Institute Of Technology, Vellore

  Analytical Chemistry