Nareshkumar Pothamsetty

Dynamic Pharmaceutical Production & Quality Leader with 18+ years of experience in oncology, sterile injectables, lyophilized products, and biopharmaceutical manufacturing. Expertise in oncology injectable manufacturing (cytotoxic & high-potency drugs), aseptic filling, vial washing & lyophilization, production planning & manpower handling, validation (IQ/OQ/PQ), media fill & process validation, EU GMP, USFDA, WHO compliance.

Head Production Operations and Quality of Injectables - Euploid Pharmaceuticals Pvt Ltd - Mysore, Karnataka

(2025-06)

To ensure Quality Assurance activities and Regulatory departments and injectable Production operations Project (New)

Head – Production Operations & Quality of Injectables - Axa Parenterals Ltd. - Haridwar

(2020-05 - 2025-06)

• Successfully cleared WHO-GMP & EU-GMP audits with strong compliance track record
• Reduced deviations by 20% through robust CAPA, QMS strengthening, and investigation systems
• Managed end-to-end production compliance, process validation, and cleaning validation
• Oversaw aseptic manufacturing operations, sterile area qualification, and documentation systems
• Lead pharmacovigilance activities, product complaints, recall management, and risk assessment

Manager – Production Operations & Compliance (Walk through Audit) (Oncology & General Block) - Hetero Labs Ltd., Unit V & Unit VI (Oncology) - Telangana

(2016-05 - 2020-05)

Worked in a USFDA-approved oncology manufacturing facility handling regulated markets. Specialized in lyophilized oncology injections with focus on aseptic processing. Managed cytotoxic (oncology) and general sterile production blocks. Ensured compliance with cGMP, USFDA, EU GMP, and data integrity requirements. Led QMS activities including deviations, CAPA, change control, and audit readiness.

Sr. Executive – Biotech Manufacturing / QA (Oncology Division) - Reliance Life Sciences Pvt. Ltd. - Navi Mumbai

(2014-01 - 2016-05)

Worked in Unit 3 & Unit 6 – Oncology Division, focusing on biotech sterile manufacturing of oncology biologics in compliance with cGMP standards. Gained exposure to biosimilars, monoclonal antibodies (mAbs), and targeted oncology therapies in biologics manufacturing. Involved in aseptic processing, process validation, and GMP documentation systems, ensuring compliance with cGMP and regulatory requirements.

Supported technology transfer, batch release, and QA oversight activities, ensuring compliance with cGMP and regulatory requirements. Maintained compliance with EU GMP, Annex 1, and regulatory guidelines for highly potent compounds.

Junior Manager – Biopharmaceutical / Oncology Manufacturing - Dr. Reddy's Biologics - Hyderabad

(2011-05 - 2014-01)

Worked in an oncology biosimilars manufacturing facility with exposure to regulated markets (USFDA, EMA, WHO), ensuring strict adherence to cGMP and global regulatory standards. Gained hands-on experience in upstream (mammalian cell culture, bioreactor operations) and downstream processing (chromatographic purification, UF/DF) for biologics manufacturing. Involved in bioreactor operations (USP), filtration, chromatography (DSP), and aseptic handling of biologics in compliance with cGMP standards.

Supported process validation, technology transfer, and batch manufacturing activities in compliance with cGMP and regulatory requirements. Ensured compliance with cGMP, ICH guidelines, and global regulatory requirements for biologics manufacturing across regulated markets.

Executive Production - Pfizer Ltd - Chennai & Visakhapatnam

(2008-01 - 2011-01)

Expertise in Cephalosporin, Penem, and Betalactum Dry powder injection sections.

• Production planning & execution
• Aseptic filling, vial washing & lyophilization
• BMR/BPR documentation
• Validation & qualification activities
• Deviation handling & CAPA implementation
• Manpower & resource management

Ph.D. - Biotechnology - Maharaja Agrasen University (2022-01)

M.Sc. - Microbiology - Yogi Vemana University (2006-01 - 2008-01)

B.Sc. - Biotechnology - Sri Venkateswara University (2003-01 - 2006-01)