Madhu Shudhakar is a quality control professional with over 10 years of experience seeking a managerial role. He has a strong background in quality assurance and ensuring compliance with domestic and international regulatory standards through testing, inspections, and handling of audits. His expertise includes establishing quality systems, managing analytical equipment and laboratory teams, and supporting new product development.

1. MADHU SHUDHAKAR.M
Flat # D1-16 Huda colony chanda nagar, Hyderabad-500050
Mobile: 9177542066 ~ E-Mail: Madhuiict2002@gmail.com
Subject: Managerial Assignment in Quality Control – Pharmaceutical Industry
Dear Sir/ Ma’m
Against your expressed requirement of an appropriately qualified candidate for the subject position, I avail this occasion to
endorse my resume for perusal and consideration.
Having contributed over 10.0 years and above predominantly in leadership roles in quality control domain with different -
companies, I have played vital role in establishing quality centric image of the company. I have set up quality control
systems and procedures and ensured strict enforcement thereof to ensure no tolerance culture in quality function. I have
effectively managed wide range of tests/ inspection procedures in conformance with domestic / international regulatory
regime and the latest cGMP requirements. I hold strong credentials of facing regulatory audits like US FDA, EDQM, WHO
and ISO including audits from customers abroad. I have acquired wide experience in handling sophisticated analytical
instruments like HPLC, GC, UV, IR, DISSOLUTION and providing troubleshooting support. I have built, trained and retained
teams of qualified professionals and inspired confidence among them to work as cohesive unit of performers.
With trail of impeccable performances, I seek career realignment in managerial role in quality control domain with a
reputed company in pharmaceutical /allied industry. I am confident to provide positive leadership and make visible
contribution to growth and profitability of the company.
My enclosed resume shall take you through the details and I hope my professional acquisitions would provide a perfect
match with the job profile. I shall be glad to receive a call for an interview personal or telephonic, as convenient.
I am readily accessible on my telephone numbers mentioned on the top of this letter
Thanks and Regards,
Madhu Shudhakar.M

2. MADHU SHUDHAKAR.M
Flat # D1-16 Huda colony chanda nagar, Hyderabad-500050
Mobile: 9177542066 ~ E-Mail: Madhuiict2002@gmail.com
QUALITY CONTROL PROFESSIONAL – PHARMACEUTICAL INDUSTRY
Seeking managerial role in Quality Control with a progressive company in pharmaceutical industry in India & Abroad
PROFILE
• A competent and committed quality control professional with career success of over 10.0 years predominantly in
leadership roles with different – different companies. Currently positioned as Executive in Quality Control department
with Natco Pharma Ltd, Hyderabad..
• Demonstrated functional excellence in defining and enforcing quality systems and procedures to minimize junk
generation and enhance overall quality-centric image of the company. Strong record of arranging product/process/
method validations and calibration of analytical instruments/ equipments.
• Capable of managing /performing wide range of tests/ inspection procedures in conformance with domestic and
international regulatory regime. Proven expertise in preparation and review of data for new projects as per the latest
cGMP requirements.
• Strong record of facing regulatory audits like USFDA, EDQM, WHO, MHRA, TGA, ANVISA and MCC various customer
audits from abroad.
• Well organized, diligent and detail-oriented with fine tuned analytical and problem solving skills. Effective team leader,
trainer and motivator with ability to build and retain teams of performers. Superior verbal and written communication
skills.
Key Strength Areas
● Quality Assurance / QC● Testing & Inspection procedures ●Process Improvements ● Calibration/ Validations ● Quality
Systems/ SOPs ● Standardization ● Quality Audit /Documentation ● Training & Development ● Lab Management
●Procurement ● Cross Functional Coordination.
PROFESSIONAL EXPERIENCE
NATCO PHARMA LTD, HYDERABAD May 2014 – Present
Executive (Quality Control department)
DR. REDDY’S LABORATORIES LTD, HYDERABAD Dec 2009 – May2014
Sr Team Member (Quality Control department)
MYLAN LABORATORIES LTD, NASIK June 2006 – Dec 2008
Chemist
IICT, HYDERABAD May 2005 – June2006
Project Assistant
IICT, HYDERABAD Oct 2001 – June2003
Project Trainee
Responsibilities
• Drawing daily work plan of the lab and defining work allocations for the analysts to conduct analysis of in-process,
intermediates and finished products, stability analysis.
• Defining Standard Operating Procedures for the department, effectively handling Validation, Quality documentation,
Maintenance of control samples, Procurement of reference standards, Validation of Q.C. instruments, and equipments
and reviewing Calibration activities and maintenance of control samples. Developing new methods for regular
products.
• Ensuring completion of analytical documentation relating to in process, finished product and validations and Stability
samples.
• Conducting training sessions for Quality Control Chemists as per GLP, cGMP guidelines.
• Handling of Out Of Specification and Out Of Trend investigation.
• Identifying requirement of chemicals, new analytical instruments etc and arranging timely procurement to support lab
operations.
• Imparting training to new joining on system and SOPs. Reviewing documents generated for responding queries from
different regulatory authority. Providing support for gap analysis for line extension products.

3. • Ensuring all the products have clearly defined specifications with careful & sophisticated quality control measures in
compliance to the international standards.
• Shouldering the onus of inspecting, designing and developing Pharmaceutical Products and reviewing Batch
manufacturing record review and release of finish product. Coordinate with various stake holders for preparation of
Validation Protocol, Validation Reports, and preparation of Data Analysis & Trending.
• Executing the stability program of intermediate products and finished product as per regulatory requirement.
• Handling market complaints and providing best possible service within stipulated time. Coordinating with supplier/
manufacturers on day to day quality and manufacturing issues.
INSTUMENTS HANDLED
• HPLC (Waters with Empower software PDA (2998) & UV detector).
• HPLC Agilent 1200 series with Empower software
• Gas Chromatography (Agilent 6890N with Empower software).
• UV-Visible Spectrophotometer (Shimadzu-2450 series).
• Dissolution Test Apparatus (Electrolab, Distek& Lab India).
• Disintegration Apparatus..
• FTIR (Jasco and Shimadzu).
• Karl-fischer titrator.
EDUCATION
Master in Science (Chemistry); 2005
S.V University;
Bachelor of Science;
S.K University 2001
Date of Birth: 1st
June 1981
References: Available upon request