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
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Languages
kannada
Native language
English
Advanced (C1)
C1
Interests
Travel
Painting
Writing
Software
3DX - PLM System
Empower
Work Preference
Work Type
Full TimeLocation Preference
RemoteHybridOn-SiteImportant To Me
Career advancementWork-life balancePersonal development programsTeam Building / Company RetreatsQuote
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