Summary
Overview
Work History
Education
Skills
Courses
Internships
Awards and Achievements
Timeline
Hi, I’m

Sagar M S

Quality Assurance
Mysore
Sagar M S

Summary

A Quality Domain Professional with 5 plus years of experience in the field of Quality Assurance in Pharmaceutical/CRO sector.

Collaborative leader partners with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

Overview

7
years of professional experience
3
Languages

Work History

Pharmaleaf India Pvt Ltd

Manager CQA (Corporate Quality Assurance)
03.2025 - Current

Job overview

  • Top Deliverables
  • QMS
  • Audits Mangement
  • Vendor Management
  • Controlled Document Managemet
  • Compliance

Labcorp Drug Development

Controlled Docs Sr Coordinator-QA
05.2024 - 03.2025

Job overview

  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
  • SME for Qdocs (Veeva Vault)
  • Performing the QMS activities as and when required using Veeva QMS
  • Supporting the technical queries regards to Qdocs docs (Veeva vault) to end users
  • Complete required trainings according to required timelines.
  • Administer controlled documents ensuring availability to the end user.
  • Ensure timely escalation of issues and resolution management impacting controlled document release.
  • Supporting the Matrices for Controlled documents for the department Supporting on the work simplification projects
  • Perform the change control activities regards to the Controlled documents (SOPs,WIs,Policies etc,)
  • Support for Monthly matrices for the organization regards to controlled documents.

Labcorp Drug Development

QA Controlled Docs Coordinator(RCQA), Global Quality Office
12.2021 - 05.2024

Job overview

  • Follow applicable departmental Standard Operating Procedures and Work Instructions.
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
  • SME for Qdocs (Veeva Vault)
  • Supporting on the work simplification projects Perform the change control activities regards to the Controlled documents (SOPs,WIs,Policies etc,)
  • Complete day-to-day tasks ensuring quality and productivity.
  • Other duties as assigned by management.

Cipla Pharmaceutical Ltd.

Senior Executive (QA-QMS)
03.2021 - 12.2021

Job overview

  • Monitoring of compliance with the requirement of Current Good Manufacturing Practices
  • Ensure for availability of Current and Approved SOP’s.
  • Evaluation of change controls related to SOP and BMR and study impact related to changes.
  • To Perform activities related to issuance of BMR and BPR.
  • To Perform activities related to release of MBMR and MBPR.
  • To Perform activity related to blocking of obsolete production version of MBMR/MBPR in SAP.
  • Ensure that the required initial and continued training of department’s personnel are carried out according to the need.
  • Preparation, Compilation, Review and Submission of APQRs as per schedule. Identify areas of Work Simplification.
  • To Perform change control related activities through CIPDOX (Document management system)
  • Product Dossier review. To ensure the sourcing of material, manufacturing and testing is carried out as per dossier, accepted for registration by concern regulatory agency. Preparation of documents required for regulatory affairs. Improvement, continuous review and upgradation of existing SOP’s.
  • Ensure online documentation and timely entries of all operations /activities and the entries are properly initiated with date.
  • To provide compliance of internal and external quality audits.
  • To operate various software systems like Cipdox, track wise and Learning Management System (LMS) etc. Based on the roles and rights provided in the applications.

Mylan Laboratories Ltd.

Apprentice (QA-Documentation)
07.2018 - 07.2019

Job overview

  • To Perform uploading and or retrieving of designated documents as required by current procedures in “Document Management System” (Documentum)
  • To provide compliance of internal and external quality audits.
  • To operate various software systems like Cipdox, track wise and Learning Management System (LMS) etc. Based on the roles and rights provided in the applications.

Education

Adichunchangiri University

M.Pharm from Pharmaceutical Analysis
07-2021

University Overview

Rajiv Gandhi University of Health Sciences

B.Pharm
08-2018

University Overview

Adichunchangiri University
Mandya

PhD
11-2027

University Overview

Skills

Veeva QMS

Courses

Courses
  • Inorim Lifesciences, Drug Regulatory Affairs June 2020 — August 2020
  • ISO9001:2015 QMS Implementation , Asian Institute of Quality Management July 2021 — August 2021
  • Special Upskilling Programme by Drug Regulatory Affairs(DRA) , Define Academy June 2022 — August 2022

Internships

Internships
  • Intern at Karnataka Antibiotics and Pharmaceutical Ltd, Bangalore July 2017 — August 2017
  • Intern at Jubilant Generics Ltd., Nanjangud, Mysore November 2017 — December 2017

Awards and Achievements

Awards and Achievements

Best Outgoing Student (B.Pharm)

Recognized as the Best Outgoing Student during B.Pharm.

Adarsha Vidyarthi Award (PUC)

Received Adarsha Vidyarthi Award for academic excellence

Guest Lecturer

Delivered guest lectures on the Pharmaceutical Industry and Quality Assurance in several colleges

Career Excellence Awards

Awarded for achieving excellence as part of the ACE program in Bengaluru

Timeline

Manager CQA (Corporate Quality Assurance)
Pharmaleaf India Pvt Ltd
03.2025 - Current
Controlled Docs Sr Coordinator-QA
Labcorp Drug Development
05.2024 - 03.2025
QA Controlled Docs Coordinator(RCQA), Global Quality Office
Labcorp Drug Development
12.2021 - 05.2024
Senior Executive (QA-QMS)
Cipla Pharmaceutical Ltd.
03.2021 - 12.2021
Apprentice (QA-Documentation)
Mylan Laboratories Ltd.
07.2018 - 07.2019
Adichunchangiri University
M.Pharm from Pharmaceutical Analysis
Rajiv Gandhi University of Health Sciences
B.Pharm
Adichunchangiri University
PhD

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Sagar M SQuality Assurance