Nagaraju Damera

Results-driven Senior Analytical Scientist and QC Manager with 16+ years of progressive pharmaceutical experience across India and the United Kingdom. MHRA-regulated UK experience (RSSL / Mondelez International, Reading, UK) provides a significant advantage for multinational pharmaceutical environments in the UAE. Deep hands-on expertise in HPLC/UPLC method development and validation (ICH Q2(R1)), QC laboratory operations, batch release testing, finished product testing, stability studies (ICH Q1A), OOS investigations, CAPA, and Data Integrity (ALCOA+) compliance.

Proven leadership in managing QC teams of 5–10 analysts, driving GMP manufacturing support, achieving zero critical audit findings across USFDA and MHRA inspections, and authoring CTD Module 3 dossiers for ANDA/NDA submissions. Seeking a senior Analytical R&D, QC leadership, or Analytical Lead role within the UAE pharmaceutical industry.

Scientist I — Analytical R&D - Reading Scientific Services Ltd (RSSL / Mondelez International) - Reading, UK

(2023-08 - 2025-12)

UK — MHRA Regulated

• Executed HPLC/UPLC method validation and verification for Assay, Related Substances, Dissolution, Content Uniformity, and KF per ICH Q2(R1); ensured full GMP manufacturing support for pharmaceutical clients in an MHRA-regulated environment.
• Led OOS investigations, deviation management, and CAPA implementation — reduced repeat deviations through improved root cause analysis and documentation controls across LIMS, Q-Pulse, and ELN platforms (ALCOA+ compliant).
• Managed batch release testing and finished product testing workflows; reviewed and approved analytical data prior to product disposition in compliance with GMP/GLP standards.
• Qualified and troubleshot analytical instruments (HPLC: Waters/Agilent/Shimadzu, UV-Vis, KF, FT-IR, dissolution); reviewed IQ/OQ/PQ calibration records to maintain QC laboratory operations readiness.
• Authored regulatory documentation and MHRA audit dossiers; trained and mentored a team of junior analysts, raising GMP compliance standards and laboratory productivity.

QC & Analytical R&D Manager - MSN Laboratories Pvt. Ltd. - Hyderabad, India

(2020-07 - 2023-04)

• Directed QC laboratory operations and ICH stability programmes for oncology tablets and sterile injectable products (USFDA / global markets) — managed a team of 8 analysts ensuring timely batch release testing and finished product testing to GMP standards.
• Reviewed and approved analytical data for Assay, Related Substances, Dissolution, pH, KF, and % Transmittance; maintained full ALCOA+ data integrity compliance across all laboratory records.
• Resolved complex HPLC, dissolution, and stability-indicating method failures through systematic root cause analysis — minimised project timeline impact and supported GMP manufacturing operations.
• Authored CTD Module 3 analytical sections and ICH stability summaries for multiple ANDA submissions; achieved zero critical GMP findings during concurrent USFDA and MHRA inspections.
• Supervised ICH Q1A(R2) stability studies (long-term, accelerated, intermediate) — ensured rigorous data trending, statistical evaluation, and regulatory compliance throughout product lifecycle.

Scientist III — Analytical Development - Ricon Pharma India Pvt. Ltd. - Hyderabad, India

(2016-11 - 2020-01)

• Designed, validated, and transferred 8+ HPLC/UPLC stability-indicating methods for sterile injectables and solid oral forms per ICH Q2(R1) — covering specificity, precision, accuracy, linearity, range, and robustness.
• Managed end-to-end analytical method transfers from R&D to QC; prepared transfer protocols, conducted comparative testing, performed statistical evaluation, and resolved discrepancies to ensure QC laboratory readiness.
• Reviewed IQ/OQ/PQ instrument qualification documentation; initiated and managed change controls and deviation investigations with full CAPA implementation.
• Maintained GMP documentation including SOPs, specifications, analytical test methods, and logbooks in strict accordance with ALCOA+ data integrity principles.

Scientist I — Formulation Analytical R&D - Eugia Pharma Research Centre (Aurobindo Group) - Hyderabad, India

(2014-08 - 2016-11)

• Executed full method verification studies (accuracy, precision, specificity, linearity, robustness, system suitability) and led R&D-to-QC technology transfers for finished pharmaceutical products.
• Led API vendor qualification through comparative assay, impurity profiling, residual solvents analysis, and physicochemical characterisation across multiple API sources; reviewed DMFs and quality compliance records.
• Established standardised verification and vendor qualification protocols, directly reducing QC analytical transfer failures and improving batch release timelines.
• Managed working reference standard qualification — preparation, characterisation, potency assignment — and maintained all associated GMP documentation.

Research Executive — Analytical R&D - Sai Life Sciences - Pune, India

(2013-02 - 2014-08)

• Delivered injection compatibility studies for parenteral oncology products, supporting IND/NDA package development and regulatory submission timelines.
• Conducted GMP-compliant batch testing, method verification, and analytical method transfers; maintained laboratory records in full conformance with ALCOA+ principles.

Research Associate IV — Analytical R&D - Aurobindo Pharma Limited - Hyderabad, India

(2008-02 - 2012-08)

• Performed routine QC batch release testing and finished product testing of tablets, capsules, and injectables using HPLC, UV-Vis, dissolution, and wet chemistry techniques.
• Conducted ICH stability studies, supported regulatory submission data, and executed particle size analysis (Malvern laser diffraction) for solid oral and injectable formulations.

M. Pharmacy - Pharmaceutical Chemistry - Rajiv Gandhi University of Health Sciences, Bangalore, India (2007)

B. Pharmacy - Rajiv Gandhi University of Health Sciences, Bangalore, India (2005)

D. Pharmacy - Diploma in Pharmacy - V.L. College of Pharmacy, Raichur, India (2000)