Kumar Bnn

  • Bangalore Karnataka
Kumar Bnn

Skills

Skills

Nova LIMS software

This Software is

Window word, Excel, Power point

Interest

Preparation, Review of technical documents of Pharmaceutical industries like SOP, IOP, GAM, Protocol, Reports

Commission of new analytical lab - Qualification of instruments, Facility qualifications etc

Training - Training of new recruits, Training on Technical documentation and implementation

Custom

  • Training- cGMP and Quality systems
  • Qualification of new instruments[DQ/IQ/OQ/PQ]
  • Post qualification performance verification of Analytical instruments.
  • Work closely with the Quality Management Department to prepare audit readiness documentation
  • Provide status reports to reporting manager. Communicate quality issues and concerns to reporting manager and study team management as appropriate
  • Drive the implementation of corrective actions when necessary, including retraining
  • Perform and/ or coordinates new hire trainings as well as regular staff trainings. Share audit findings as lessons learned. Create best practice documents.

Work History

Work History

Organization                      :          Enzene biosciences, Bangalore.

Designation                        :          Research Associate

Institution/Organization : Shridevi research and diagnostic center /Vidyavahini institutions, Tumkur

Designation                        :  Faculty [Dept. of Biochemistry]

Organization                      : Strides Arco lab ltd., Bangalore

Designation                        :  Trainee Executive

Sep 2008 - Present

Assistant Manager, Quality Control, Quality systems

Biocon Limited, A Pharma Division
  • Planning and implementing the methods of working, direction of quality control inspection systems & reporting procedures.
  • A keen knowledge in designing and development of the analytical lab.
  • Knowledge of Qualification of instruments for analytical purpose.
  • Expertise in preparation of trends, AMC and PM programs for calibration/performance of instruments and Qualification of Excel sheet for analytical calculation purpose.
  • Strategic planning of Employee training to cope with the standards of the company and regulatory expectations by ensuring job descriptions, CVs and Training records according to applicable SOPs.
  • Possess excellent managing skills, team building and coordination with internal departments
Apr 2007 - Sep 2008

Jr. Executive in Quality Control department

Kemwell Pvt Limited, Bangalore, A Pharma Division
  • Release Testing [in process and finished products] of Oral drops, Creams, Shampoos and ointments
  • Working Standard Preparation
  • Operation and Calibration of laboratory instruments
  • Non routine works like checking and updating of calibration status for instruments/Reviewing of SOP’s/preparation of Analytical Raw data sheets
  • Facility validation of Oral solid unit – Water system
  • Instrument operation – HPLC, GC, Polorimeter, MP apparatus, Viscometer, FTIR.
  • Regulatory / Audit exposure - Have knowledge of Indian guidelines of GMP (Schedule M), ICH guidelines, Exposed to customer audits of companies like GSK, Cipla, Novartis, Johnson & Johnson, Bayer’s etc

Education

Education
Nov 2005 - Jul 2007

M.phiL.,

Bharathidasan University
Jun 1997 - Jun 1999

M.Sc,

Bangalore university

Certifications

Certifications

Quality auditor

QA - Biocon limited

Nova LIMS software operation certification

Novatek