Open to opportunities

Harsh Patel

@harshpatel5

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Experienced QC Executive in pharmaceuticals with regulatory expertise.

India

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What I'm looking for

I am looking for a challenging role in a growth-oriented company that values quality and compliance.

I am a skilled professional with over 7 years of experience in the pharmaceutical industry, specializing in quality control and regulatory compliance. My journey has taken me through reputable organizations where I have honed my skills in managing audits and ensuring adherence to stringent regulatory standards such as USFDA, MHRA, and WHO.

Currently, I work as a QC Executive at AMN Life Science, where I lead efforts in quality management and oversee critical processes to ensure product integrity. My previous roles at Medley Pharmaceuticals and IPCA Laboratories have equipped me with a robust understanding of cGMP guidelines and the ability to handle complex analytical instruments, ensuring that all products meet the highest quality standards.

Experience

Work history, roles, and key accomplishments

QC Executive

AMN Life Science

Dec 2024 - Present (7 months)

Currently working as a QC Executive, responsible for work distribution and management, and reviewing specifications and standard testing procedures. Also involved in reviewing SOPs as per cGMP regulatory guidelines and approving analytical records.

WHO ISO TGA FTIR LOD Oven PH Meter Tablet Friability Tester SCM Trackwise MS Office PH Meters

QC Executive

Medley Pharmaceuticals

Oct 2022 - Present (2 years 9 months)

Worked as a QC Executive, successfully facing USFDA regulatory audits. Responsible for checking analytical calibration reports and attending to troubleshooting for instrumental and documentation queries.

ISO FTIR LOD Oven PH Meter Tablet Friability Tester SCM Trackwise MS Office PH Meters

QC Executive

IPCA Laboratories Ltd.

Dec 2017 - Present (7 years 7 months)

Worked as a QC Executive, successfully facing MHRA-UK & WHO regulatory audits. Ensured and managed working standards and reference standards, and provided training to personnel.