Summary
Overview
Work History
Education
Skills
Languages
Accomplishments
Affiliations
Timeline
Generic

Hariom Sharan Tiwari

Indore

Summary

Dynamic quality assurance professional with extensive experience at Cipla Ltd., specializing in compliance and continuous improvement. Proven track record in implementing corrective action plans and conducting root cause analysis, enhancing product reliability. Skilled in QMS and effective communication, driving quality initiatives that significantly reduced defect rates and improved operational efficiency.

Overview

11
11
years of professional experience
4010
4010
years of post-secondary education

Work History

Assistant Quality Assurance Manager

Cipla ltd.
Indore
03.2022 - Current
  • Assisted in developing quality assurance protocols for pharmaceutical products.
  • Conducted regular audits to ensure compliance with industry standards and regulations.
  • Collaborated with production teams to address quality concerns and implement solutions.
  • Reviewed and approved batch records and documentation for accuracy and completeness.
  • Participated in root cause analysis to identify issues affecting product quality and safety.
  • Reviewed supplier documentation for accuracy and adherence to established guidelines.
  • Analyzed statistical data gathered during inspections or tests to determine if any corrective actions need to be taken.
  • Developed and implemented quality assurance processes to ensure compliance with industry standards.
  • Investigated customer feedback regarding product defects or discrepancies in service delivery.
  • Established criteria for inspection, testing and evaluation of products prior to shipment or release into market.
  • Assisted in the development of training programs related to Quality Assurance practices.
  • Reviewed customer complaints, investigated root causes of non-conformances and developed corrective action plans.
  • Participated in internal and external audits as required by regulatory bodies such as ISO 9001, 2015 or FDA regulations.
  • Identified areas where improvements could be made within the Quality Assurance process and worked with relevant stakeholders to implement changes.
  • Ensured that all Quality Assurance personnel were properly trained on current policies, procedures and best practices.
  • Reviewed current standards and policies.
  • Conducted quality assurance audits to ensure compliance with established procedures and standards.
  • Established procedures and quality standards.
  • Inspected, removed and replaced malfunctioning equipment and tools to minimize workflow disruptions.
  • Managed continuous improvement strategies to improve manufacturing margins and reduce costs.
  • Facilitated regular quality reviews with senior management, providing insights and recommendations for quality improvement.
  • Conducted risk assessments and validation activities to mitigate potential quality and compliance risks.
  • Managed the development and maintenance of quality management systems (QMS), ensuring continuous improvement and efficiency.
  • Implemented corrective and preventive action (CAPA) systems, significantly reducing defect rates and improving product reliability.
  • Determined optimum points to sample products and created protocols to obtain reliable data.

QA Officer

Glenmark ltd.
Indore
06.2021 - 03.2022

QA executive

PSA chemicals and pharmaceutical ltd.
Indore
11.2020 - 06.2021
  • Conducted quality audits to ensure compliance with established standards.
  • Collaborated with teams to identify and resolve quality issues.
  • Assisted in developing testing protocols for new products.

QA Executive

Felix generics Pvt. Ltd.
Indore
01.2019 - 08.2020

QA Officer

Lupin ltd.
Mandideep
12.2014 - 12.2018
  • Conducted quality inspections on pharmaceutical products to ensure compliance with standards.
  • Developed and maintained testing protocols for various product lines and processes.
  • Collaborated with cross-functional teams to address quality issues and implement solutions.
  • Reviewed batch records for accuracy and completeness before final approval.
  • Trained staff on quality assurance procedures and best practices for production processes.
  • Coordinated internal audits to assess compliance with regulatory requirements and company policies.
  • Monitored equipment calibration and maintenance schedules to ensure operational efficiency.

Education

M Pharma - Pharmacy

VNSIP Bhopal
Bhopal
08.2009 - 10.2011

B Pharma - Pharmacy

VNSIP
Bhopal
08.2005 - 08.2009

DAV Public School
Bina

DAV Public School
Kakri

Skills

  • Compliance
  • IPQA
  • QMS
  • Audit trail
  • Audit compliance
  • Root cause analysis
  • Corrective action plans
  • Continuous improvement
  • Effective communication
  • Quality management systems
  • QA documentation
  • Employee training

Languages

English
First Language
Hindi
Proficient (C2)
C2

Accomplishments

  • Selected in GATE -2009 conducted by IIT with 91.58 percentile.
  • GMP performer of year for 2016-17 in Lupin ltd.
  • Silver medal in national science Olympiad at school level.

Affiliations

  • Won gold medal at state level Karate championship held in Dewas (MP) in 2013.
  • Got 1st prize at interschool level competition in essay writing.

Timeline

Assistant Quality Assurance Manager

Cipla ltd.
03.2022 - Current

QA Officer

Glenmark ltd.
06.2021 - 03.2022

QA executive

PSA chemicals and pharmaceutical ltd.
11.2020 - 06.2021

QA Executive

Felix generics Pvt. Ltd.
01.2019 - 08.2020

QA Officer

Lupin ltd.
12.2014 - 12.2018

M Pharma - Pharmacy

VNSIP Bhopal
08.2009 - 10.2011

B Pharma - Pharmacy

VNSIP
08.2005 - 08.2009

DAV Public School

DAV Public School

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Hariom Sharan Tiwari