UMAKUMAR

SARMA G.
Email ID: umakumar80@yahoo.co.in;
Phone: +91 -9966901938.

Career Overview
A determined and diligent professional having extensive experience in Quality Assurance,
Quality Control , Regulatory and Project Management functions in Pharmaceutical sector in
diverse industrial domains; Possessing strong administration, management and maintenance
skills is looking forward to excel in a reputed organization with a competing position and
managerial level obligations in QA & Regulatory Affairs Management to efficiently deliver the
competencies for the continued growth and viability of the organization
Career Summary
❒ A result oriented and competent professional with 20+ years experience in Quality
Assurance & Regulatory Functions in Pharmaceutical Industry;
❒ Experienced in Overseeing/Monitoring/Analyzing existing system and developing strategies
for productivity improvements, maximizing business growth and profits;
❒ Cohesive Leader and Team Player with capability in providing training, guiding and
motivating teams towards maximum productivity
Academic Credentials

Master of Science (Organic Chemistry)

M.V.R College, Vishakhapatnam
Post Graduate Program in Project Management.
University of Massachusetts Amherst
ISO 9001 CQI-IRCA
ISO 27001 CQI-IRCA
ZED Certified Consultant.

AUDITS
Lead Team for USFDA AUDIT 2015 and 2020
Lead Team for EDQM AUDIT 2017.
ISO Audits .
Customer audits more than 75.
Vendor Audits.
Career Summary

Free Lancer (ISO9001,ISO27001,,QA,QC and RA)

Duration: October 2023 to till date

GODAAVARILABS PRIVATE LIMITED
Designation: Senior Manager ( Quality Assurance and Regulatory Affairs)
Duration: July 2022 to September 2023
ENAL DRUGS PRIVATE LIMITED
Designation: Senior Manager (Regulatory Affairs)
Duration: Feb 2022 to June 2022
Saraca laboratories limited (Virchow group)
Designation: Manager (Regulatory Affairs ,Support to QA and QC)
Duration: July2015 to Feb2022
Siri Drugs India Pvt. Ltd
Designation: Manager (Quality & Regulatory Affairs)
Duration: October 2012 to July 2015
ARCH Pharma-Labs Ltd, Tarapur
Designation: Manager (Regulatory Affairs and support to QA ,QC activities)
Duration: April 2010 to October 2012
NUELAND Laboratories Ltd, Hyderabad
Designation: Executive (Regulatory Affairs)
Duration: May 2009 to April 2010
SHASUN Research Centre, Chennai
Designation: Officer (Analytical Development)
Duration: August 2006 to March 2009
Dr. Reddy’s Laboratories Ltd, Vizag
Designation: Senior Executive Quality Control
Duration: April 2003 to August 2006.
PROFILE:
❑ Preparation & Review of Drug Master File for US (USDMF), COS dossiers,Health Canada etc
along with Life cycle management of the Drug Master File.
❑ Handling of deficiencies related Drug Master File.
❑ Preparation & Review of Applicants Part of Drug Substance to various Customers
❑ Issuance of Letter of Authorization (LOA) to different Regulatory Authorities/Customers
❑ Preparation & Review of Technical Packages
❑ Handling Customer and Regulatory Queries
❑ Review of New Product Technology transfer document on behalf of Regulatory Function
❑ Assessment of Starting Materials, Vendor Selection and Evaluation of Potential Impurities
Carryover
❑ Review and Compliance of Pharmacopoeial Updates
❑ Designing of Specifications for Raw Materials, Starting Materials, In-Process, Intermediates
and Drug Substances
❑ Review and Approval of Change Controls
❑ Performing GAP assessment for approved documents and existing documents.
❑ Participation in Internal/External Audits for Regulatory Compliance
❑ Coordination with R&D, Production, QC & QA for Hastening Submission Procedure
❑ Operation of e-CTD Software Freyr,EDUCE etc
❑ Coordinate all Quality Assurance activity of site with Corporate Quality Assurance
 ❑ Co-Coordinating in creating and authorizing quality systems and procedures
❑ Responsible for preparation of Annual Quality product reviews, OOS/OOT.

❑ Review of analytical validations as per ICH requirements.

❑ Active Member in USFDA audits and EDQM audits.
❑ Data Integrity,21cfr.
❑ Conducting Training Classes
❑ Monitoring Laboratory Working Area and Laboratory Safety
❑ Monitoring effective functioning of QC Analytical group and QC Support group of Quality
Control Laboratory
❑ Ensure Effective Review of Analytical Reports & Approval of Analytical/Microbiological
Reports
❑ Formal Investigation of Out-of-Specification, Out-of-Trend Test Results and Errors &
Documentation of Investigation, Including Action Taken, etc
❑ Review and Approval of Schedules and Data of Calibration and Maintenance of
Instruments/Equipment
❑ Review and Approval of Protocols for different studies -Temperature Distribution Study,
Glassware/Accessories Cleaning Validations, Software Validation/Verifications, etc.
❑ Review & Approval of Analytical Method Validation/Verification and Method Transfer
Protocols and Reports
❑ Review and Approval of Specification for Input Materials, Intermediates, Active
Pharmaceutical Ingredients, Finished Products and stability products to ensure
compliance with Compendia and Company Standards
❑ Ensuring all Reserve Samples are Stored properly and at appropriate Storage Conditions as
per the Procedure Defined
❑ Updation of methods and analysis of materials as per current GLP guidelines and regulatory
requirements
❑ Approve and Monitor Contract Laboratories
❑ Approval of Stability Protocol, STF and Stability Summary
❑ Ensure Stability Studies are performed on Finished Products and Active Pharmaceutical
Ingredients at appropriate frequency as per protocols and certify relevant documents.
❑ Responsible to maintain sufficient retention samples of Starting Materials and Finished
Product
❑ Examine Returned Materials/Preparations to determine whether such Preparations should
be Released, Reprocessed or Destroyed
❑ Conducting Technology/Method Transfer Activity
❑ Performing cut off studies related to DMF Filling
❑ Method Development by Malvern, HPLC
❑ Project Management
❑ ISO Audits
❑ Vendor Audits
Technical Proficiency
MS Office (Word, Power Point, Excel)
Submission of DMFs through e-CTD
Method Validation and Development, Transfer, Verifications
Well versed with HPLC, GC, IC, ICP- OES, UV, IR, Malvern Audit Trials, 21 CFR, GLP.
LIMS,GMP Pro,SAP.
Personal Dossier
Date of Birth : 27th January 1980
Linguistic skills : English, Telugu & Hindi
Nationality : Indian
Father’s Name : Shr. G. U.N. Dakshina Murthy
I do hereby declare that the details provided by me in this resume are correct and I have
knowingly not omitted/ misrepresented any information. I am aware that the company can use
this data for verification purposes and any material inconsistency identified between the details
shared above versus actual information would have a bearing on my employment, based upon
company policies.
UMAKUMAR SARMA G.