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Yesubabu Nalamolu

@yesubabunalamolu

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Experienced Quality Control Manager in the pharmaceutical industry.

India

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What I'm looking for

I am looking for a role that challenges me and allows for professional growth while contributing to a team focused on quality and compliance.

With over 22 years of extensive experience in Quality Control and Analytical Research and Development within the pharmaceutical industry, I have honed my expertise in advanced instrumentation techniques such as HPLC, GC, and ICP-MS. My career has been marked by a commitment to ensuring compliance with Good Laboratory Practices (GLP) and regulatory standards, leading teams through successful regulatory inspections with minimal observations.

As a General Manager at Cronus Pharma, I oversee a 60-member team, managing all aspects of Quality Control and Analytical R&D. My leadership has been pivotal in implementing procedural improvements and addressing complex regulatory queries, ensuring alignment with international standards. I am passionate about fostering a culture of quality and compliance, and I thrive in environments that challenge me to innovate and improve operational excellence.

Experience

Work history, roles, and key accomplishments

Current

General Manager - Quality Control

Current

Cronus Pharma Specialties India Pvt Limited

Dec 2023 - Present (1 year 6 months)

As General Manager, I oversee Quality Control and Analytical R&D with a 60-member team, ensuring compliance with quality systems and managing internal and regulatory audits. I am responsible for method development, validations, and responding to regulatory queries.

Quality Control Analytical Development Compliance Management Team Leadership

Head of Quality Control

Suven Pharmaceuticals Limited

Oct 2013 - Dec 2023 (10 years 2 months)

Led an 80-member team in the API division, overseeing all QC activities, ensuring compliance with quality systems, and managing audits. Responsible for method development, validations, and handling OOS investigations, while implementing SOPs and training staff.

Quality Control Team Leadership Regulatory Compliance Audit Management Change Control

Dy. Manager - Quality Control

Mylan Laboratories Limited

Dec 2009 - Oct 2013 (3 years 10 months)

Managed a 12-member team in the Quality Control department, focusing on instrumental analysis and method transfers. Responsible for laboratory investigations, instrument maintenance, and handling regulatory queries.

Quality Control Method Transfer Laboratory Investigations Data Management Team Coordination Compliance

Sr. Executive - Analytical Method Validation

Strides Arcolabs Limited

Jun 2008 - Jan 2010 (1 year 7 months)

Worked in the Analytical method validation team, validating drug substances and dosage forms as per regulatory requirements. Focused on HPLC and Gas Chromatography methods.

Analytical Methods Validation Gas Chromatography Regulatory Compliance Drug Substance Quality Assurance Documentation Team Collaboration

In Charge - Stability Studies

Cipla Ltd.

Mar 2006 - Jun 2008 (2 years 3 months)

Managed stability studies of APIs, preparing protocols, reviewing reports, and maintaining stability chambers. Participated in technology transfer of analytical methods across various sites.

Reports Stability Chambers Technology Transfer Quality Control Regulatory Compliance Team Coordination Documentation

Chemist - Quality Control

Matrix Ltd.

Jun 2004 - Mar 2006 (1 year 9 months)

Conducted analysis of residual solvents and monitored reaction mass of API products. Involved in troubleshooting HPLC and preparing working standards.

Quality Control Residual Solvent Analysis HPLC Troubleshooting Compliance working standards preparation

Quality Control Chemist

Inventaa Chemicals Limited

May 2002 - Jun 2004 (2 years 1 month)

Responsible for sampling and testing raw materials and finished products, ensuring quality standards were met. Involved in standardization of volumetric solutions.