Summary
Overview
Work History
Education
Skills
Websites
Personal Information
Personal Qualifications
References
Training
University
Disclaimer
Exposure
Accomplishments
Software
Certification
Cricket, Music
Quote
Timeline
AccountManager
Satish Honmute

Satish Honmute

Pharmaceutical Quality Assurance
Bangalore,Karnataka

Summary

  • To make a solid contribution towards the organization by utilizing my skills, experience, and knowledge for the growth of the organization and enhance professional skills.
  • Performance driven pharmaceutical professional with 16+ years of experience in pharmaceutical Quality Assurance.
  • Quality Management Systems
  • Audits & Compliance
  • Change Management
  • Complaint Management
  • Deviation and CAPA Management
  • GxP Training Management
  • In-process Quality Assurance (IPQA)
  • Certified Six Sigma Green Belt
  • Document Control and Management
  • APQR
  • CSVC
  • Investigation Management

Dedicated pharma professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.

Overview

15
15
years of professional experience
3
3
Certifications
3
3
Languages

Work History

Senior Manager, Quality Assurance

Biocon Pharma Ltd
5 2021
  • QMS Management, Change control/Deviation/Complaint/Investigation Management, Document Control and Management, Audit and Compliance, APQR, Management Review and Training Management

Team Leader, Quality Systems

Apotex Research Pvt. Ltd
10.2018 - 05.2021
  • Site Change Control, CAPA and Training Management

Senior Reviewer II, Quality Systems

Apotex Research Pvt. Ltd
07.2017 - 09.2018
  • Deviation Investigations management

Senior Reviewer II, QA Operations

Apotex Research Pvt. Ltd
07.2016 - 06.2017
  • QMS activity for QA Operations

Senior Reviewer I, QA Operations

Apotex Research Pvt. Ltd
06.2014 - 06.2016
  • IPQA -Shift In charge

Officer-Production

Okasa Pharma (P) Ltd
06.2007 - 03.2010
  • Production activity - Tablet Compression and Coating

Medical Representative

Claris Lifesciences Limited
02.2007 - 05.2007
  • Cardio-Diabetic division

Trainee Pharmacist (Q.C.)

Sewa Medicals Ltd
07.2006 - 01.2007
  • In-process quality control activity during pre-fillable syringe components manufacturing

Education

SVPM's college of pharmacy, Malegaon, Baramati (PUNE University)

Skills

Self-motivated

Strong technical, communication, and documentation skills

Knowledge of quality assurance functions

In-process quality assurance

Change control management

CAPA and deviation/complaint investigation

Training management

Regulatory and cGMP compliance

Planning and executing daily activities

Change management

Manufacturing activities management

Ensuring compliance to quality standards

Learning content development

GxP learning projects

Review and approval of Deviation/Market Complaint investigation, CAPA, Change controls

Document Control and Management

In-process Quality Assurance (IPQA)

Sincere, honest, and dedicated towards work

Proactive attitude and quick learner

Ability to work under pressure

Punctual and eager to learn

Implementation in time

Adaptivity with the environment

Efficiently working with Microsoft Software's, SAP System, and TrackWise System

Excellent Power Point Presentation skills

Certified Business Intelligence using Power BI

Basic understanding of LIMS

Documentum Software

Cross-Functional Collaboration

Troubleshooting and problem resolution

Data-driven decision-making

Problem-solving abilities

Analytical Skills

Process Improvement

Multitasking

Excellent Communication

Positive Attitude

MS Office

Self Motivation

Continuous Improvement

Multitasking Abilities

Adaptability

Attention to Detail

Personal Information

  • Passport Number: N1905650
  • Date of Birth: 07/26/1985
  • Marital Status: Married

Personal Qualifications

B. Pharmacy

References

Will be furnished based on request.

Training

  • Certified Lean and Six Sigma Green Belt
  • Certified lead investigation and QA approver for Deviation investigations
  • Attended workshop on Human Reliability Program
  • Attended workshop on Investigation Basics and Root cause analysis
  • Attended Webinar on Technical writing
  • Attended Webinar on Quality Risk Management
  • Attended Webinar on Excel Spreadsheet validation in a GxP Environment

University

PUNE University

Disclaimer

I hereby declare that the information furnished by me above is true to the best of my knowledge.

Exposure

Exposure to solid oral dosage forms such as Tablets and Capsules (Potent and non-potent molecules)

Accomplishments

  • Faced and cleared the various regulatory inspections viz. USFDA, MHRA, Health CANADA, IGJ, ANVISA, etc.
  • Effectively implemented electronic Document Management System (DMS) application at Biocon Pharma Ltd. for management of documents.
  • Instrumental in implementing the Human Reliability Program (Reduction of Human errors) and preparation of Quality Risk Assessment with respect to Cross Contamination.
  • Successfully developed and delivered innovative learning/training programs such as Quality Beyond Compliance and Effective SOP Writing.
  • Successfully completed the assignments such as Data Integrity Risk Assessment (DIRA) and Project- Excellence.
  • Developed self-skills to achieve Quality, Productivity and Management

Software

Trackwise

DMS

SAP

LIMS

Microsoft Power Point

Microsoft Excel

Power BI

Certification

Lean and Six Sigma Green Belt

Cricket, Music

Cricket is not just a hobby for me; it's a deep-seated passion that brings joy and excitement to my life. Being part of a cricket team has added a whole new dimension to my hobby. The camaraderie and teamwork forged on the field are unlike any other, creating bonds that go beyond the boundaries of the game. As I watch and admire my favorite cricket players and teams take the field, I draw inspiration from their talent and dedication.

Listening to music allows me to unwind, relax, and recalibrate my mood. Music has the incredible ability to speak to the depths of my soul, resonating with feelings and thoughts that are sometimes difficult to express in words. Certain songs have become the soundtrack of my life, marking important moments and milestones with their poignant lyrics and melodies.

Quote

If you do the right thing, it will comply with all the regulations

Timeline

Business Intelligence using Power BI

03-2023

Lean and Six Sigma Green Belt

11-2020

Team Leader, Quality Systems

Apotex Research Pvt. Ltd
10.2018 - 05.2021

Lead investigation and QA approver

07-2018

Senior Reviewer II, Quality Systems

Apotex Research Pvt. Ltd
07.2017 - 09.2018

Senior Reviewer II, QA Operations

Apotex Research Pvt. Ltd
07.2016 - 06.2017

Senior Reviewer I, QA Operations

Apotex Research Pvt. Ltd
06.2014 - 06.2016

Officer-Production

Okasa Pharma (P) Ltd
06.2007 - 03.2010

Medical Representative

Claris Lifesciences Limited
02.2007 - 05.2007

Trainee Pharmacist (Q.C.)

Sewa Medicals Ltd
07.2006 - 01.2007

Senior Manager, Quality Assurance

Biocon Pharma Ltd
5 2021

SVPM's college of pharmacy, Malegaon, Baramati (PUNE University)
Satish HonmutePharmaceutical Quality Assurance