Amarnadh Nanduri

Results-driven pharmaceutical Quality professional with 18+ years' experience, including 12 years in leadership/managerial roles across complex injectables, oncology and combination products. Expertise in QMS, regulatory compliance, laboratory operations, investigations, risk management, audit readiness and continuous improvement. Proven ability to lead cross-functional teams, manage critical quality events and deliver sustainable CAPA in highly regulated environments.

Sr. Manager – Analytical & QC Department - SIMSON LIFESCIENCES PVT. LTD. (CRO) - Hyderabad

(2025-09)

• Strategic leadership of Analytical Development & QC; assign responsibilities, monitor performance and deliver departmental quality objectives.
• SME for Quality Systems, laboratory operations, compliance and validation; support FDA, MHRA, Schedule M and customer audits.
• Lead audit CAPA, root-cause analysis, internal audits, Data Integrity assessments, laboratory inspections and compliance reviews.
• Provide analytical and technical expertise in Nitrosamine impurities, Elemental Impurities, Genotoxic Impurities, method optimization, analytical method validation, verification, and method transfer.
• Review laboratory performance, quality events, deviations, investigations, and critical findings, and escalate significant issues and trends to senior management with appropriate recommendations.
• Oversee analytical testing, stability, troubleshooting and critical data trending across APIs, intermediates and finished dosage forms.
• Technical expertise in nitrosamine, genotoxic and elemental impurities, method optimization, validation, verification and transfer.
• Oversight of GC-MS/MS, LC-MS/MS, HPLC, GC, ICP-MS, KF, potentiometric titration, UV-Vis, FTIR, viscosity, dissolution and particle-size analysis.

Manager – Analytical Service Department - JANSAT LABS PVT. LTD. (CRO) - Hyderabad

(2024-05 - 2025-08)

• Led Analytical Development with responsibility for quality, compliance, audit readiness, departmental performance and delivery.
• SME for Quality Systems, Analytical Operations, Compliance and Validation during FDA, MHRA, Schedule M and customer audits.
• Led audit CAPA closure, self-inspections, stability commitments and management reporting with trend analysis.

Assistant Manager – Analytical Department | Validation, Training & Audit Facing - ACTIMUS BIOSCIENCES PVT. LTD. (CRO) - Visakhapatnam

(2022-02 - 2024-05)

• Led analytical compliance, resource readiness and audit support; coordinated risk-based audit actions and critical-finding escalation.
• Reviewed calibration records, supported Data Integrity audits/laboratory inspections, and provided expertise in assay optimization, validation and transfer.
• Perform and oversee the analysis of pharmaceutical products for Nitrosamine Impurities, Genotoxic Impurities, Assay, Dissolution, Related Substances, and Content Uniformity.
• Managed cGMP analytical operations and supported nitrosamine, genotoxic impurity, extractable/leachable, dissolution, related-substances and stability programs.

Scientist-II – Formulation Analytical Research & Development - AUROBINDO PHARMA LIMITED – RC-II - Hyderabad

(2015-12 - 2022-02)

• Supported liquid injectables, solid orals, ophthalmic solutions and syrups through analytical development and project execution.
• Guided analysts on method development, analysis planning, results interpretation and cGMP/GLP compliance; prepared technical reports and technology-transfer documentation.
• Coordinated customer interactions, technical meetings and Analytical QA activities.

Senior Executive – Analytical Formulation Development - SHILPA MEDICARE LIMITED – R&D UNIT - Visakhapatnam

(2013-06 - 2015-12)

• Executed analytical method validation, transfer and verification; prepared validation protocols for assay, cleaning, related substances and dissolution; supported nitrosamine/genotoxic impurity programs.

Senior Research Scientist – Analytical Research & Development - CYMBIOTICS BIOPHARMA PVT. LTD. (CRO) - Bangalore

(2012-06 - 2013-06)

• Reviewed/approved protocols, reports and quality documents; conducted line clearance/in-process checks; prepared/reviewed process validation, stability, hold-time and cleaning-validation documents.

Officer – Analytical Research & Development - NATCO PHARMA LTD. - Hyderabad

(2009-12 - 2012-06)

• Performed analytical and cleaning validation for solid oral and injectable products; conducted dissolution, process validation, stability, hold-time and excipient studies.

Chemist – Analytical Research & Development - ZENARA PHARMA PVT. LTD. - Hyderabad

(2008-09 - 2009-12)

• Performed analytical method validation for nicotine gums/lozenges and dissolution analysis for extended-release lozenges.

M.B.A.

• International Business - Annamalai University (2012)

P.G. Diploma - Regulatory Affairs & Quality Assurance - Annamalai University (2009)

M.Sc.

• Analytical Chemistry - Aditya PG College, Kakinada (Andhra University) (2008)

B.Sc.

• M.P.C.
• Aditya Degree College, Kakinada (Andhra University) (2006)