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Phaniraj Karlapudi

@phanikarlapudi

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Experienced General Manager with expertise in Quality Assurance and Compliance.

India

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What I'm looking for

I am looking for a challenging role that fosters growth, innovation, and a commitment to quality in the pharmaceutical industry.

I am a seasoned professional with over 20 years of versatile experience in the pharmaceutical industry, specializing in Quality Assurance and Analytical Development. Currently, I serve as the General Manager of ARD/QC at SLB Pharma Pvt Ltd, where I lead analytical development and technology transfer initiatives in compliance with GXP systems. My role involves ensuring that all materials, products, and processes meet stringent specifications and regulatory requirements, while also managing a team dedicated to operational excellence.

Throughout my career, I have demonstrated a strong commitment to quality and compliance, successfully implementing quality systems and adhering to cGMP regulations. My hands-on experience includes developing and validating analytical methods for various dosage forms, managing laboratory operations, and conducting audits to maintain high standards. I take pride in my ability to influence and guide teams, ensuring that we not only meet but exceed industry standards.

Experience

Work history, roles, and key accomplishments

Current

General Manager-ARD/QC

Current

SLB Pharma Pvt Ltd

May 2023 - Present (2 years 2 months)

Working as General Manager-ARD/QC in a CRO from May-2023 to till the date. Active participation in analytical development to technology transfer in compliance with GXP systems. Hands-on experience in presenting the regular updates, developments and Project progress to hierarchy.

DI Policies Validation Technology Transfer Nitrosamines Genotoxic Impurities SOPs Secondary Standards Impurity Standards MS Analysis Hold Time Study Degradation Study Flash Chromatography Recruitment Training 3M Utilization

General Manager-ARD/QC

ESPI Industries

Oct 2021 - Apr 2023 (1 year 6 months)

Responsible for Equipment/instrument procurement, qualification, validations, calibrations and troubleshooting of testing facility. Development, Validation of Analytical test procedures and transfers as per regulatory / market and customer requirements including impurity profiling and Stability studies. Hands-on experience in resolving QMS events like lab incidents, OOS/OOT, change controls, CAPA

SOPs Qualification Validation Equipment Calibration Sachets FDA Internal Accreditations Impurity Profiling ERP SAP Lab Incidents Change Control CAPA Outsourcing Bottle

Senior Manager-ARD/QC

Evertogen Life Sciences Pvt Ltd

Apr 2017 - Oct 2021 (4 years 6 months)

Designing cost effective, robust analytical method development for all types of dosage forms with Scientific and regulatory approach. Responsible for ARD & QC functions to meet method development, validation, transfer, timely releases of Materials/In process stage Sample to final batch dispatch. Faced as direct department representative for regulatory audits like USFDA, MHRA, UKRAINE MOH, HEALTH C

Analytical Methods Validation FP Batches ARD Validation FaSSGF Reports UKRAINE MOH WHO Customer Audits

Deputy Manager-ARD

Epione Labs Pvt Ltd

Aug 2013 - Apr 2017 (3 years 8 months)

Worked as Deputy Manager-ARD. Responsible for various analytical development activities and supporting the team in achieving project milestones. Contributed to the overall quality assurance processes within the organization.

Analytical Development Quality Assurance Project Management Team Leadership Documentation

Team Lead-Analytical

Disto Pharmaceutical Pvt Ltd

Jan 2010 - Jul 2013 (3 years 6 months)

Served as a Team Lead-Analytical. Managed a team of analytical professionals and oversaw various analytical testing procedures. Ensured compliance with quality standards and regulatory requirements.

Team Leadership Quality Control Regulatory Compliance Data Analysis

Sr. Executive-ARD

Inventis Drug Delivery Systems Pvt Ltd

May 2005 - Dec 2009 (4 years 7 months)

Worked as a Sr. Executive-ARD. Involved in research and development activities related to drug delivery systems. Contributed to the formulation and testing of new pharmaceutical products.

research and development Drug Delivery Quality Assurance