Summary
Quote
Overview
Timeline
Work History
Skills
Software
Accomplishments
Certification
Interests
Work Availability
Education
Work Preference
Generic
Sreejith Purushan

Sreejith Purushan

Pharmaceutical Quality Assurance Leader
Bangalore,KA

Summary

A seasoned Senior Quality Assurance Manager with an impressive 17 plus years experience in the pharmaceuticals, I bring a wealth of expertise in upholding and enforcing rigorous quality standards that align seamlessly with regulatory and accreditation mandates. My adeptness in implementing Total Quality Management strategies has consistently ensured the delivery of high-caliber products for the organizations I have served. I excel in proactive risk assessments and strategic compliance actions, driving reductions in failures and minimizing complaints. In my role as a pharmaceutical leader, my unwavering commitment is to ensure the safety, efficacy, and quality of products released to the market. I lead by example, motivating and inspiring teams to adhere to Good Manufacturing Practices and uphold meticulous documentation processes. With a relentless dedication to excellence, I aim to foster a culture of quality assurance and regulatory compliance within the organization, driving continuous improvement and maintaining the highest standards in pharmaceutical manufacturing.

Quote

"Quality is not just a standard; it's an attitude."
Sreejith Purushan

Overview

17
17
years of professional experience
8
8

Plus years in managerial role

50
50

Team handled

2
2

Certifications

5
5

Appreciations

Timeline

CQI / IRCI Certified ISO 9001:2015 Lead Auditor Course (B.S.I)

04-2024

Lean Six Sigma Black Belt (IASSC)

02-2024

Senior Manager Quality Assurance

MEDREICH PLC
06.2023 - Current

Senior Manager Quality Assurance

ACME GENERICS PRIVATE LIMITED
03.2022 - 06.2023

Senior Manager Quality Assurance

MICRO LABS PRIVATE LIMITED
01.2020 - 02.2022

Manager Quality Assurance

MEDOPHARM PRIVATE LIMITED
08.2015 - 12.2019

Sr. Executive - Quality Assurance

MICRO LABS LTD
04.2012 - 07.2015

Executive - Quality Assurance

MICRO LABS LTD
12.2009 - 03.2012

Officer - Development QA

MARKSANS PHARMA
12.2007 - 12.2009

Bachelor of Science - Chemistry

Sathyabama University
03.2004 - 05.2006

Work History

Senior Manager Quality Assurance

MEDREICH PLC
06.2023 - Current
  • Regulatory Compliance Assurance and Liaison, Quality Management Oversight, QA Systems Implementation and compliance, Product Compliance and Batch Release to QP for certification, CMO & Vendor Audit, Qualification and Compliance, Staff Training, Team Management and Strategic Planning, Complaints and Recall Handling, Collaboration with teams and Customer Service support, Document Review and Approval, Quality Review Meetings, Inspection Handling, Technical Agreement compliance

Senior Manager Quality Assurance

ACME GENERICS PRIVATE LIMITED
03.2022 - 06.2023
  • Quality Lead for overall Quality Assurance Functions and Quality management system activities at manufacturing, testing and Release Facility.

Senior Manager Quality Assurance

MICRO LABS PRIVATE LIMITED
01.2020 - 02.2022
  • Quality Lead for overall Quality Assurance Functions and Quality Management System activities at manufacturing, testing and release facility.

Manager Quality Assurance

MEDOPHARM PRIVATE LIMITED
08.2015 - 12.2019
  • Handling of Overall Quality Assurance Functions and Quality Management System activities.

Sr. Executive - Quality Assurance

MICRO LABS LTD
04.2012 - 07.2015
  • Handling of Quality Management System documents, Audit compliance, Preparation and Review of investigations related to Market complaints, Preparation of Standard Operating Procedures and Quality Assurance Procedures, Handling and Review of Vendor Approval documents, Preparation of Quality Risk Assessment reports, Monthly Quality System Review, Monitoring of Validation and Qualification activities

Executive - Quality Assurance

MICRO LABS LTD
12.2009 - 03.2012
  • Preparation and Review of Master BMR and BPR, Preparation and Review of Validation Protocols and compilation of reports, In-process Quality Assurance activities at shop floor, Review of executed batch records and packing records, Preparation and compilation of Product Quality Reviews

Officer - Development QA

MARKSANS PHARMA
12.2007 - 12.2009
  • Preparation of Batch manufacturing records and Master Manufacturing records, Process Validation Protocols and Reports for new products, Preparation of Product Development Reports,
  • Coordinating for arranging training programs in the department, Preparation and Review of Training files and records of all the personnel in the department.

Skills

Certified Quality Auditor

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Software

EQMS-Electronic Quality Management System

EDCS: Electronic Document Management System

LMS: Learning (Training) Management System

ELOG: Electronic Logs and Formats

EBMR: Electronic Batch Processing and Compliance

I CLEEN: Cleaning Validation electronic platorm

VQ: Vendor Management and Qualification

SAP: Resource Processing and Release

LIMS: Laboratory Management System

Accomplishments

  • Lead Two New Plant Projects from its Construction to Qualification, Implementation of Quality Management System, Technology Transfer of Products, Submission to Agency, Audit and Commercialization of product successfully.
  • USFDA audit with 'Zero' 483
  • ANVISA audit with 'Zero' non compliance

Certification

CQI / IRCI Certified ISO 9001:2015 Lead Auditor Course (B.S.I)

Interests

Pets

Cricket

Cooking

Gardening

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Education

Bachelor of Science - Chemistry

Sathyabama University
Chennai, India
03.2004 - 05.2006

Work Preference

Work Type

Full Time

Location Preference

On-SiteRemoteHybrid

Important To Me

Company CultureWork-life balanceCareer advancementPersonal development programs
Sreejith PurushanPharmaceutical Quality Assurance Leader