NAIMISH MISHRA
Quality Assurance
Visakhapatnam,Andhra Pradesh
Summary
Pharmaceutical Professional with M.Pharm (Pharm. Analysis and QA) and MBA (Pharmaceutical Management) qualification and total of around 14 years of experience in Investigations,Audits and compliance, Quality Culture Transformation, Compliance, QMS, and Qualification and Validation of liquid parenteral and Oral solid dosage formulations.
Experience in handling regulatory audits of USFDA (USA), ROB (Germany) ANVISA (Brazil), INFARMED (Portugal), GCC (Gulf Region), South Africa (MCC), Australia (TGA), Germany, Russia, Ukraine and Belarus, Libya and various internal and external customer audits.
Overview
14
14
years of professional experience
8
8
years of post-secondary education
Work History
Site Lead-Investigations
Dr. Reddy's Laboratories Ltd.
Visakhapatnam
01.2021 - Current
- Facilitate, Coach and train staffs for building robust root cause analysis culture to eliminate non-conformance. Participate and help team to conclude complex problems by providing logical conclusion. Help improve process robustness by designing robust CAPAs.
SME Team Leader
Dr. Reddy's Laboratories Ltd
Visakhapatnam
01.2016 - 12.2020
- Managed all regulatory, customer and internal audits and its timely response with adequate CAPAs
- Worked as SME for Investigations and CAPA, Culture and Communications, GEMBA, Standardization of practices, QC Robustness, Facility upkeep and Engineering standards across Dr. Reddy's laboratories sites.
- Responsible directly for designing, implementing and monitoring of interventions for Investigation quality enhancement and QC robustness across all Dr. Reddy’s Sites
- Also contributed for Team member and lead of Investigations for Site Investigation Team at Sterile Injectable facility of Dr. Reddy’s Laboratories. Includes OSD manufacturing as well.
- Awarded as best Mentor/Guide, Chairman's excellence award for outstanding contribution in enhancing quality culture
Senior Executive, Compliance
Hospira, A Pfizer Company
Visakhapatnam
04.2014 - 09.2014
- Responsible for Investigations and CAPA for Liquid parenteral preparations (SVP).
Executive- Quality Assurance
Aurobindo Pharma Ltd
Hyderabad
12.2009 - 03.2014
- Qualification of critical process equipments, area, HVAC systems, NVPC systems and Validation of process, cleaning, aseptic process.
- Responsible for QMS activities like Investigations, Change controls, Market complaints, Audits and responses
- Awarded as Quality Champion
Education
MBA - Management
ICFAI Tripura
Tripura, India 08.2017 - 07.2019
Masters in Pharmacy - Pharmacy (Pharm. Analysis And Quality Assurance)
Biju Patnaik University of Technology
Odisha 07.2007 - 05.2009
Bachelor of Pharmacy - Pharmacy
Biju Patnaik University of Technology
Odisha 08.2003 - 05.2007
Skills
Investigation, Audit and Compliance, Regulatory guidances,Training and mentoring
undefinedAdditional Information
- Good listening skills
- Good at Human error Investigations
- Trained for Six Sigma Green Belt
- Industry 4.0 trained for AI, ML applications in Pharma
- Part of digital lighthouse initiative
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Tough times never last,But tough people do!! Together we are stronger!!
Naimish
Timeline
Site Lead-Investigations
Dr. Reddy's Laboratories Ltd.
01.2021 - Current
MBA - Management
ICFAI Tripura
08.2017 - 07.2019
SME Team Leader
Dr. Reddy's Laboratories Ltd
01.2016 - 12.2020
Senior Executive, Compliance
Hospira, A Pfizer Company
04.2014 - 09.2014
Executive- Quality Assurance
Aurobindo Pharma Ltd
12.2009 - 03.2014
Masters in Pharmacy - Pharmacy (Pharm. Analysis And Quality Assurance)
Biju Patnaik University of Technology
07.2007 - 05.2009
Bachelor of Pharmacy - Pharmacy
Biju Patnaik University of Technology
08.2003 - 05.2007
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