Summary
Overview
Work History
Education
Skills
Certification
Personal Information
Disclaimer
Work Availability
Languages
Interests
Software
Work Preference
Quote
Timeline
Generic

MURALIDHARA K V

Bangalore

Summary

To work for an organization that utilizes the best of my caliber and looking for a prospect where technical competencies valued, and I can make a meaningful contribution to the growth of the organization.

Overview

1
1
Certification

Work History

Lead engineer

HCL Technologies
Chennai
- Current
  • Initiation of project activities by doing a gap assessment based on the scope
  • Preparation of CIP (Change implementation plan) for the different projects
  • Update of Product specifications, Artwork requirement specification, Risk report, design verification, validation documents and other design documents based on the project requirements
  • Post market surveillance activities like preparation of PM Plan, PMS report for different product groups
  • Preparation of Complaint Trending Analysis report for the different product groups
  • Creation of eDHF baseline for the different product groups
  • Performance of Configuration Control Audit for the deliverables and other project files to achieve good PCI score
  • Knowledge on Design master record, Design input, design output and design transfer documents
  • Knowledge about ISO 13485, ISO 14971
  • Basic knowledge on 21 CFR guidelines related to Medical devices.

Medical device Quality Control Executive

Biocon Biologics
Bangalore
  • Execution of different laboratory tests like Dose accuracy, Friction force analysis, Injection force analysis for the different products
  • Have experience in the new instrument installation activity including IQ, OP, PQ and CSV activity
  • Handling of Deviations activities by performing Hypothesis tests based on the requirements
  • Stability samples laboratory analysis for different products
  • Maintenance of reserve samples
  • Knowledge and adherence ISO 13485, ISO 9001, ISO 11608, ISO 14971

Quality Control Executive

Advanced research facility MICRO LABS
Bangalore
  • Analysis of assays and RS for various drug products in HPLC
  • Method validation and verification in HPLC, UPLC, and IC
  • Preparation of Method validation, verification protocols and reports
  • Instrument installation activity including IQ, OP, PQ and CSV activity
  • Handling of Change controls which are related to laboratory and SOP documents
  • Review of documents.

Quality Control Executive

Biocon ltd.
Bangalore
  • Handling of various laboratory instruments like FTIR, PSD, SOR, HPLC
  • Taking care of regular batch release within time
  • Adherence to Data integrity policy (ALCOA and ALCOA +)
  • Adherence to Good laboratory practice and good documentation practice.

Education

Master of Science [MSc] - Seri Biotechnology (Life science)

University of Mysore
01.2016

Bachelor of science [BSc] - Chemistry, Botany, Zoology

Govt. science college, Hassan
01.2014

PUC - Physics, chemistry, mathematics, biology

BGS PU College,Arakalagudu
01.2011

SSLC -

Adarsha rural high school, Agrahara

Skills

  • Initiation of project activities
  • Preparation of CIP (Change implementation plan)
  • Update of Product specifications, Artwork requirement specification, Risk report, design verification, validation documents and other design documents
  • Post market surveillance activities
  • Preparation of PM Plan, PMS report
  • Preparation of Complaint Trending Analysis report
  • Creation of eDHF baseline
  • Performance of Configuration Control Audit
  • Knowledge on Design master record, Design input, design output and design transfer documents
  • Knowledge about ISO 13485, ISO 14971
  • Basic knowledge on 21 CFR guidelines related to Medical devices
  • Execution of different laboratory tests
  • Experience in new instrument installation activity including IQ, OP, PQ and CSV activity
  • Handling of Deviations activities
  • Stability samples laboratory analysis
  • Maintenance of reserve samples
  • Knowledge and adherence ISO 13485, ISO 9001, ISO 11608, ISO 14971
  • Analysis of assays and RS for various drug products in HPLC
  • Method validation and verification in HPLC, UPLC, and IC
  • Preparation of Method validation, verification protocols and reports
  • Instrument installation activity including IQ, OP, PQ and CSV activity
  • Handling of Change controls related to laboratory and SOP documents
  • Review of documents
  • Handling of various laboratory instruments like FTIR, PSD, SOR, HPLC
  • Taking care of regular batch release within time
  • Adherence to Data integrity policy (ALCOA and ALCOA )
  • Adherence to Good laboratory practice and good documentation practice

Certification

  • Pharmacovigilance, clinical research course, Indian healthcare BPO, 03/2019, 09/2019
  • Quality control analyst, Azyme biosciences, 2017

Personal Information

  • Father's Name: M Venkatesh
  • Mother's Name: Shreelakshmi
  • Title: Lead engineer
  • Date of Birth: 04/26/94
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Single

Disclaimer

I hereby declare that the information given above is true to the best of my knowledge and belief.

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse

Languages

kannada
Native language
English
Advanced (C1)
C1

Interests

Travel

Painting

Writing

Software

3DX - PLM System

Empower

Work Preference

Work Type

Full Time

Location Preference

RemoteHybridOn-Site

Important To Me

Career advancementWork-life balancePersonal development programsTeam Building / Company Retreats

Quote

The way to get started is to quit talking and begin doing.
Walt Disney

Timeline

Lead engineer

HCL Technologies
- Current

Medical device Quality Control Executive

Biocon Biologics

Quality Control Executive

Advanced research facility MICRO LABS

Quality Control Executive

Biocon ltd.

Master of Science [MSc] - Seri Biotechnology (Life science)

University of Mysore

Bachelor of science [BSc] - Chemistry, Botany, Zoology

Govt. science college, Hassan

PUC - Physics, chemistry, mathematics, biology

BGS PU College,Arakalagudu

SSLC -

Adarsha rural high school, Agrahara
MURALIDHARA K V