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Pushpendra SinghPS
Looking for a job

Pushpendra Singh

@pushpendrasingh7

I support GMP fermentation and regulatory documentation for pharmaceutical manufacturing.

India
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What I'm looking for

I'm seeking a Regulatory Affairs or CMC role where I can apply my technical pharmaceutical knowledge, GMP documentation experience, and understanding of US FDA, EMA, CDSCO, CTD/eCTD, and DMF requirements.

I'm currently performing upstream fermentation and manufacturing activities at Lyfius Pharma Pvt. Ltd. (Aurobindo Pharma), working under GMP, SOPs, and process controls.

I manage inoculum development, sub-culturing, media preparation, culture monitoring, fermenter sampling, sterility checks, microscopy, plate counting, and colony morphology assessment. I also draft and revise GMP-aligned SOPs and contribute quality documentation used in regulatory submissions.

Through BITP training at Lyfius Pharma, I gained exposure to Regulatory Affairs, QA, QC, DMF concepts, customer documentation, deviation handling, CAPA, change control, and audit readiness. I'm seeking a Regulatory Affairs or CMC role where I can apply my pharmaceutical regulatory and technical knowledge.

Experience

Work history, roles, and key accomplishments

LL
Current

Upstream Fermentation Microbiologist

Lyfius Pharma Pvt. Ltd.

Oct 2024 - Present (1 year 11 months)

Performs upstream fermentation and manufacturing activities in compliance with GMP, SOPs, and process controls. Manages inoculum development, sub-culturing, and in-process sample testing including pH, PMV, sterility checks, and microscopy.

Education

Degrees, certifications, and relevant coursework

Indira Gandhi National Open University logoIU

Indira Gandhi National Open University

Post Graduate Diploma, Intellectual Property Rights

Pursuing a Post Graduate Diploma in Intellectual Property Rights.

University of Jammu logoUJ

University of Jammu

Master of Science, Biotechnology

Grade: CGPA: 8.69

Completed Master of Science in Biotechnology with a CGPA of 8.69.

CSJM Kanpur University logoCU

CSJM Kanpur University

Bachelor of Science, Chemistry, Zoology, Botany

Grade: 61.8%

Completed Bachelor of Science with a focus on Chemistry, Zoology, and Botany, achieving 61.8%.

Tech stack

Software and tools used professionally

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