BALAMURUGAN G
Karaikal
Summary
Dynamic Quality Control leader with a proven track record at Sthree Chemicals, adept in SOP Implementation Strategies and showcasing exceptional analytical skills. Excelled in enhancing QC lab analysis accuracy by 50%, demonstrating strong leadership and Equipment Reliability Improvement. Passionate about driving quality excellence and operational efficiency in the pharmaceutical sector.
Overview
21
21
years of professional experience
Work History
HEAD QC (QUALITY CONTROL)
STHREE CHEMICALS PVT LTD
Chennai
11.2023 - Current
- Company Overview: Sthree Chemicals is one of the big players in bulk drugs, having a standard like USFDA, MHRA, WHO, EU, KFDA, and audited by all major international regulatory agencies.
- Its group of Nuray Chemicals Pvt Ltd.
- Expert quality control manager with exceptional leadership skills, and dedication to customer satisfaction.
- Strong analytical abilities and strategic planning skills are needed to develop effective QC procedures and efficient solutions to address production issues, improve operational efficiency, and reduce overall project costs.
- Excellent communication skills to collaborate with internal managers, QC team members, and production technicians, as well as to maintain strong and loyal customer relationships.
- Develop comprehensive quality control requirements and procedures for each project, including product sample rates, QC rating scales, and flowcharts for solving production issues.
- Interface directly with clients to determine appropriate QC requirements prior to the production run, provide quality assurance information throughout production, and ensure customer satisfaction at project completion.
- Identify, evaluate, and implement a continual improvement exercise to improve QC productivity, as well as simplify systems and procedures.
- Updated the quality procedures in line with the regulatory guidelines.
- Addressed US FDA deficiencies, coordination with RA.
- Timely completion of lab investigations and reduction of repetitive lab events.
CHIEF MANAGER-HEAD QC (QUALITY CONTROL)
MALLADI DRUGS & PHARMACEUTICALS LTD
Chennai
04.2018 - 11.2023
- Malladi Pharma recognized as a leading manufacturer of bulk drugs.
- Oversee all quality control operations, including making team assignments, providing support to junior QC analysts, and completing annual performance reviews.
- Perform quarterly testing and optimization analysis on QC equipment to ensure correct operational performance and results.
- Guide and monitor the team in ensuring compliance for planned events, such as revalidation as per validation master plans, calibration, and preventive maintenance plans for events, such as any changes in the area, equipment, or process involved in the plant, and also in the case of the introduction of new products or any other unplanned events, in order to ensure the facility and processes are in a validated state.
- Updated the quality procedures in line with the regulatory guidelines.
- Reduction of repetitive, unconfirmed OOS.
- Addressed US FDA deficiencies, coordination with RA.
- Timely completion of lab investigations and reduction of repetitive lab events.
MANAGER (QUALITY CONTROL)
SUN PHARMA INDUSTRIES LTD
Chennai
11.2016 - 03.2018
- Company Overview: Sun Pharma is one of the big players in bulk drugs and formulation, having standards like USFDA, MHRA, WHO, EU, KFDA, and Mexican FDA, and is audited by all major international regulatory agencies.
- Monitoring adherence to quality systems, complying with quality standards, and maintaining requisite documents.
- Provide inputs in investigations related to OOS, and lab events.
- Engage with employees; direct and guide the team on departmental issues; provide on-the-job training to team members.
- Good handling and troubleshooting knowledge of various laboratory equipment.
- Identifying the scope for the implementation and monitoring of technological changes to enhance productivity.
- Review of Standard Operating Procedure, Specifications, and Standard Testing Procedures.
- To ensure all the operations are conducted as per SOPs.
- Review of analytical method validation protocols and reports.
- Optimum utilization of staff and resources, with very good planning.
- Liable for cGMP activities, following up on the cGLP, regulatory guidelines, and the related documentation work.
- Reduction of repetitive, unconfirmed OOS.
- Timely completion of lab investigations and reduction of repetitive lab events.
- Training was provided, and the development of the QC lab analysis reduced human error and instrument-related error by 50%.
- Instrument breakdowns were minimized, and proper maintenance of QC laboratory instruments was ensured.
- HPLC and GC method issues identified.
MANAGER (QUALITY CONTROL)
NURAY CHEMICALS PVT LTD
Chennai
10.2012 - 11.2016
- Acknowledged by USFDA, WHO, and other regulatory agencies for meeting compliance standards.
- Review and approval of specifications, standard testing procedures, and annual product quality records.
- Development of analytical methods and validations.
- Review and approval of analytical method validation protocols and reports.
- Identify, evaluate, and implement a continual improvement exercise to improve QA productivity, as well as simplify systems and procedures.
- Ex-automation process, or reduced testing, increases shelf life in order to ensure quality improvement, reduction in lead times, better product availability, and reduced cost of poor quality and productivity.
- Review of documentation prior to product release.
- Approve or reject quality notifications, such as incident reports, change controls, and out-of-specification (OOS) cases, in a quality and timely manner, and ensure investigations of failures or complaints and responses to stakeholders.
- Updated the quality procedures in line with the regulatory guidelines.
- Addressed US FDA deficiencies, coordination with RA.
SENIOR EXECUTIV(ASSISTANT MANAGER) (QUALITY CONTROL)
SHASUN PHARMACEUTICALS LTD
Chennai
02.2012 - 10.2012
- Renowned player in the bulk drugs and formulation industry with USFDA, MHRA, WHO, EU, KFDA, Mexican FDA standards.
- Guide and monitor the team in reviewing, facilitating, and adhering to quality systems related to product stability, and intimate regulatory authorities (internal and external) in case of failed studies on a proactive basis.
- Enforce budgetary discipline in the function.
- Coordinate with the Marketing and R&D departments.
- When required for resolving conflicting market requirements and priorities.
- Identify, evaluate, and implement a continual improvement exercise to improve QA productivity, as well as simplify systems and procedures.
- Review of documentation prior to product release
- Approve or reject quality notifications, such as incident reports, change controls, and out-of-specification (OOS) cases, in a quality and timely manner, and ensure investigations of failures or complaints and responses to stakeholders.
- Optimum utilization of staff and resources, with very good planning.
- Prepared the plant to attain US FDA, WHO (twice), KFDA, and Mexican FDA approvals.
- Addressed the various regulatory deficiencies (USFDA, EUGMP, WHO) in coordination with RA.
SENIOR EXECUTIVE (E4 LEVEL)
AUROBINDO PHARMA LTD
Visakhapatnam
04.2008 - 02.2012
- Established Aurobindo Pharma as a major player in the API sector.
- Responsible for charging and analyzing the holding time study.
- Monitoring the QC activities as per the requirements of GLP guidelines.
- Providing technical guidance and training to all subordinates working in the department.
- Timely dispose of the leftover samples after analysis.
- To ensure all the operations are conducted as per SOPs.
- Responsible for training and analyst validation for all employees.
- Any other work delegated by superiors.
- To maintain all the instruments and equipment in working condition.
- Responsible for monitoring and reviewing all cleaning validation, analyst validation activities, and their documentation.
- To ensure deviations, if any, are documented, explained, investigated, and reported to the manager for corrective action.
- Coordinating with related departments during internal audits, quality reviews, and other exercises.
- Responsible for the preparation of audit compliance reports and OOS investigations.
- Aurobindo Pharma is one of the big players in APIs, having standards like those of the FDA, MHRA, and WHO, and is audited by major international regulatory agencies.
QUALITY CONTROL EXECUTIVE
SRI KRISHNA PHARMACEUTICALS LTD
Hyderabad
03.2007 - 04.2008
- Leading API provider complying with FDA, MHRA, WHO standards.
- Preparation and review of standard testing procedures (STPs) and standard operating procedures (SOPs).
- Review of all instrumentation-related logbooks.
- Preparation and review of all worksheets related to in-process and finished product analysis.
- Planning and organizing of in-process and finished product analysis.
- Team member in the self-inspection team for GMP internal audits.
- Section In-Charge for the Instrumental Analysis Laboratory and Wet Analysis Laboratory.
- Analyzing day-to-day samples of raw materials, packing materials, in-process, finished products, and stability validation samples as per specifications.
- Conducting laboratory instrument calibrations.
- Conducting a preventive maintenance program for laboratory instruments.
- Updated the procedures as per regulatory guidelines.
QUALITY CONTROL EXECUTIVE
COVALENT LABORATORIES (P) LTD
Hyderabad
08.2003 - 03.2007
- Regular audits by major international regulatory agencies ensure compliance.
- Analyzing day-to-day samples of raw materials, packing materials, in-process products, finished products, stability, and validation samples as per specifications using microbial techniques and instruments like HPLC, GC, UV, and IR.
- Executing analytical methods, transfers, and validations.
- Conducting laboratory instrument calibrations.
- Conducting a preventive maintenance program for laboratory instruments.
- Handling inventory management in the laboratory, executing assigned work activities as per the sample plan, and recording and reviewing analytical data.
- Prepared the plant to attain WHO GMP approvals.
Education
P. G. Diploma - Industrial Water and Waste (Water Treatment)
Alagappa University
TN, India01.2000
M.Sc. - Chemistry
Annamalai University
TN, India01.1999
B.Sc. - Chemistry
Bharathidhasan University
TN, India01.1997
Skills
- System Setup Validation
- Equipment Maintenance Management
- Equipment Reliability Improvement
- Calibration Expertise
- SOP Implementation Strategies
- Resource Allocation Planning
- Compliance Audits
- 21CFR Part 11 Knowledge
- Data Backup Management
- Vendor Performance Review
- Safety Standards Enforcement
- Verification of Analytical Procedures
- CGMP Compliance Expertise
- CGLP
- GDP
- Quality Control Instrument Troubleshooting
- Advanced HPLC Techniques
- Gas Chromatography Analysis Skills
- Gel Permeation Chromatography Expertise
- Experience with Ion Chromatography Techniques
- Proficient in LCMS
- GCMS Knowledge
- FT-IR Data Analysis Skills
- DSC
- Polarimeter
- Analytical skills
- Laboratory Microbiology Techniques
- Quality Management Systems
Organizationaldetails
- Sthree Chemicals Pvt Ltd (Group of Nuray Chemicals Pvt Ltd), Head-QC, 11/01/23, Present, ISO 9001, ISO 14001, TGA, USFDA, WHO
- Malladi Drugs & Pharmaceuticals Ltd, Head-QC, 04/01/18, 11/30/23, ISO 9001, ISO 14001, TGA, USFDA, WHO
- Sun Pharmaceuticals Industries Ltd, Manager, 11/01/16, 03/31/18, ISO 9001, TGA, USFDA, WHO
- Nuray Chemicals Pvt Ltd, Manager, 10/01/12, 11/30/16, USFDA, WHO
- Shasun Pharmaceuticals Ltd, Senior Executive (Assistant Manager), 02/01/12, 10/31/12, ISO 9001, TGA, USFDA, WHO
- Aurobindo Pharma Ltd, Senior Executive (E4 Level), 04/01/08, 02/29/12, ISO 9001, TGA, USFDA, WHO
- Sri Krishna Pharmaceuticals Ltd, Sri Krishna Drugs Ltd, Executive, 03/01/07, 04/30/08, ISO 9001, TGA, USFDA, WHO
- Covalent Laboratories (P) Ltd, Executive, 08/01/03, 03/31/07, ISO 9001:2000, 14001, 2004 WHO GMP
References
- Mr. D.Balasubramanian, Head- QC, Hikal Ltd, Bangalore, +919100787166
- Mr. K.Sureshbabu, Vice-President- Quality, Hikal Ltd, Bangalore, +919944426555
Synopsis
Head-QC, STHREE CHEMICALS PVT LTD (GROUP OF NURAY CHEMICALS PVT LTD), Ranipet, Tamil Nadu, India, Over 20 years of experience in Bulk drugs, handling quality control in large API manufacturing organizations.
Personal Information
- Passport Number: R9129672
- Passport Date Of Issue: 07/03/18
- Passport Place Of Issue: Chennai
- Marital Status: Married
Timeline
HEAD QC (QUALITY CONTROL)
STHREE CHEMICALS PVT LTD
11.2023 - Current
CHIEF MANAGER-HEAD QC (QUALITY CONTROL)
MALLADI DRUGS & PHARMACEUTICALS LTD
04.2018 - 11.2023
MANAGER (QUALITY CONTROL)
SUN PHARMA INDUSTRIES LTD
11.2016 - 03.2018
MANAGER (QUALITY CONTROL)
NURAY CHEMICALS PVT LTD
10.2012 - 11.2016
SENIOR EXECUTIV(ASSISTANT MANAGER) (QUALITY CONTROL)
SHASUN PHARMACEUTICALS LTD
02.2012 - 10.2012
SENIOR EXECUTIVE (E4 LEVEL)
AUROBINDO PHARMA LTD
04.2008 - 02.2012
QUALITY CONTROL EXECUTIVE
SRI KRISHNA PHARMACEUTICALS LTD
03.2007 - 04.2008
QUALITY CONTROL EXECUTIVE
COVALENT LABORATORIES (P) LTD
08.2003 - 03.2007
P. G. Diploma - Industrial Water and Waste (Water Treatment)
Alagappa University
M.Sc. - Chemistry
Annamalai University
B.Sc. - Chemistry
Bharathidhasan University