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Manjula A H

@manjulaah

Assistant Manager at Biocon Limited supporting API manufacturing quality, GMP compliance, and TrackWise quality processes.

India

Message

At Biocon Limited, I’ve supported API manufacturing operations in compliance with cGMP requirements and approved procedures. I’ve managed GMP documentation and document control, and coordinated SOP preparation, review, approval, and lifecycle management.

I’ve facilitated TrackWise processes for deviations, CAPAs, and change controls, and supported audit readiness and Computer System Validation activities. My experience also includes microbiological testing, equipment qualification, and managing training compliance through SAP SuccessFactors LMS.

Experience

Work history, roles, and key accomplishments

Current

Assistant Manager

Current

Biocon Limited

Mar 2019 - Present (7 years 8 months)

Progressed from Executive to Assistant Manager across API Manufacturing, Production Microbiology, Quality Systems, Compliance, Documentation, and Validation functions. Managed GMP documentation, supported TrackWise quality processes, and participated in audit readiness and CSV activities.

API Manufacturing Microbiology Quality Management Systems GMP Documentation Document Control SOP Lifecycle Management Change Control CAPA Deviation Management Audit Readiness Computer System Validation Data Integrity Equipment Qualification Validation Documentation Training and Compliance Trackwise SAP LIMS SCADA

Education

Degrees, certifications, and relevant coursework

BITS Pilani

Certificate Program, Applied Industrial Microbiology

2018 - 2019

Completed a certificate program in Applied Industrial Microbiology from BITS Pilani from November 2018 to January 2019.

University of Mysore

MPhil, Seed Technology

Grade: 72%

Completed MPhil in Seed Technology with 72% marks. Research project focused on ACC deaminase-producing rhizobacteria for abiotic stress tolerance in sunflower.