Rishi Rudra

Motivated and honest in my approach towards work.

QA expertise on GCP in Clinical Trials (Late Phase) and ISO-NABL for Medical

Laboratories and Calibration Laboratories.

Well versed in QC and QA activities including reviewing of study protocols,

Clinical and non-clinical data, equipment maintenance records etc.

Experience of LIMS software and its use for laboratory analysis and data back-up procedure.

Laboratory overall management including SOP designing and preparation of assays,

management of Inventory of serological assays, calibration of equipment co- ordination with vendors and documentation, NABL audit preparedness etc.

Experience as a GCP auditor in BA / BE study related QA, Pathology laboratory work, deviation handling along with CAPA, Change Control procedures, SOP and

STP preparation as per EDMS software, Microbiological techniques like MLT, BET,

STERILITY, water analysis, setting up of microbiological lab as per latest quality norms.

Well versed in Immunological and biochemical assays using automated analyzers and ELISA of serological samples.

Ability to interpret and document PCR reports of Bio-Rad, Agilent and Quant 3 studio PCR equipment.

Dynamic in nature with a phenomenal track record of taking initiative, pro-

activeness, taking ownership of work and striving for the best results.

Ability to guide a team of professionals to inspire them for giving their best in their assigned responsibilities of work.

Highlymotivated, positive and goal-oriented, flexible, resourceful and committed to work.

MSc Microbiology, BSc Zoology