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Nikhil Belamkar

Principal Consultant CSV


Quality Management System professional with 12+ years experience, the experience comprises Analytical method development, Validation, transfer, Pharmaceutical Quality Management Systems ,CSV (Computer System Validation),GxP compliance and validation, including conducting GLP and GMP audits.

9 years of relevant experience with IT software applications validation and SDLC methodologies from requirements to validation (based on SDLC and industry best practices). Expertise in validation of Pharmaceutical Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5, US FDA and EU guidelines.
Strong background in FDA, ISO and EU regulations for Pharmaceutical, medical devices and healthcare; especially FDA 21CFR Part 820/Part 11 and EU Annex 11.

Also possess experience in technical reviews, new source evaluations of APIs and Excipients.Presently working with Strides Arcolab LTD as Group Leader under Pharmaceutical Quality Management Systems for analytical development lab, Quality Control lab and stability labs for US, EU and other regulated markets. Pursuing PhD in Analytical Method Development and Method Validation using DMAIC and Quality by Design approach.


Jun 2001Jun 2003

MSc Analytical Chemistry

Pune University

First Class Postgraduate in Analytical Chemistry with research.

Research Project Profile: Synthesis And Characterization Of Binary Metal Oxides For Solid Oxide Fuel Cells.


Jun 2015Jun 2015

ISO IMS Internal Auditor

MSME, Government Of India

Internal Auditor(Integrated Management Systems, ISO 9001 QMS, ISO 14001 EMS & OHSAS 18001)

Feb 2008Feb 2008

GMP Auditor

GlaxoSmithKline Pharmaceuticals LTD

Certified Level I and Level II GMP Auditor by GlaxoSmithKline Pharmaceuticals.

Work experience

Feb 2016Present

Principal Consultant CSV


 Presently on Ciber’s pay roll working with Philips Healthcare, validation centre  of excellence on US projects.

  • Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by reviewing the validation packages of IT applications in a regulated industry. 
  • Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams across Healthcare in appropriate verification and validation testing requirements. 
  • Support Quality & Regulatory Validation Operations group in following the established process and procedures for Validation in Healthcare business. 
  • Provide guidance/feedback to IT applications group in Validation compliance as per the applicable regulatory requirements and Healthcare policies and procedures. 
  • Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices. 
  • Create and revise Validation Standard Operating Procedures (SOPs) and other documentation to support the Quality System in regards to validation compliance. 
  • Recommend and lead corrective and preventive actions (CAPAs) to improve the validation practices. 
  • Provide practical solutions to a wide range of difficult challenges in IT validation independently.
  • Work independently to determine and develop solutions that are innovative, thorough, and practical.
  • Co-ordinate with all stake holders to track the deliverables timelines.
Jul 2015Feb 2016

Group Leader

Strides Arcolab Limited
  • Responsible for the Quality Management System of R&D laboratory, Quality Control Laboratory and Stability Laboratory.
  • Actively participate by being enabler and utilizing technical competencies during laboratory investigations, OOS and OOT investigations.
  • To develop, validate and transfer methods to QC labs.
  • To ensure overall quality efficiency of laboratory.
  • To ensure compliance to the regulatory requirements (US FDA and EU), commitments made and to set quality systems and procedures.
  • To ensure relevant GMP training to all staffs involved in GMP operations.
  • To ensure timely escalation of Quality related issues to management.
  • Review and Approval of SOP’s.
  • Review and Approval of deviations, Change control & OOS.
  • Conduct training with respect to GLP.
  • Ensure GLP Compliance in laboratory and participate self- inspection related activities
  • Review and Approval of product related documents.
Feb 2012Jun 2015

Asst QA Manager

The Janssen Pharmaceutical Companies of Johnson & Johnson
  • Handled Events, Deviations, CAPA and Change Control in Track wise Event Tracking System.
  • Actively participated and acted as enabler during Laboratory Investigations, OOS and OOT investigations.
  • Approved Test Methods and Specifications supporting clinical products
  • Approved Method Validation protocols and reports supporting clinical products.
  • Approved Method Transfer for clinical development and commercial products.
  • Prepared and Approved Quality Management Systems procedures.
  • Approved Clinical product’s stability study protocols and reports
  • Imparted training on cGMP as per annual schedule and procedural requirements to site.
  • Approved Instrument Qualification protocols and reports supporting business e.g. HPLC, XRD, UPLC, Dissolution Tester, Titroprocessor, Malvern Mastersizer 2000.
  • Ensured that all events/deviations, investigations, CAPA, Change Controls handled adequately & in timely manner by taking leadership.
  • Performed internal audits based on annual schedule.
  • Performed audits to qualify external strategic partners to ensure organizations’ and regulatory standards are met throughout the business.
  • Regulatory Outreach - Identified the upcoming new regulations and further performed GAP assessment for the existing Quality Systems and defined and/or follow-up for the implementation of actions.
  • Actively participated in departmental Quality Improvement Plans.
  • Actively participated in Global Compliance inspections.
  • Actively participated in regulatory inspections such as USFDA, EMEA etc.
  • Ensured Compliance of R&D laboratories as per SOPS and Regulatory expectations.
  • Significantly contributed in computerized system validations of application software as per GAMP 5 and US FDA 21 CFR Part 11.
  • Significantly contributed to uplift the compliance level of research & development as well as stability laboratories.
  • Effectively worked as matrix leader under matrix, virtual and global model.

Jun 2007Feb 2012

PR&D Assistant Manager

GlaxoSmithKline Pharmeceuticals LTD

Analytical method development, Validation, Transfer.

Computerised System Validation.

Quality and Compliance

New Source Evaluations

Process Excellence 

Lead and managed team of 5 analytical development scientists

Oct 2005Jun 2007

Sr.Analytical Scientist-I

Novartis PVT LTD

Analytical method development, Validation and Transfer. 

Computerised System Validation

Information Security Officer for R&D site 

May 2005Oct 2005

Research Associate

Emcure LTD

Analytical method development, Validation and Transfer. 

Jan 2004May 2005

Research Associate


Analytical Method Development, Validation and Transfer.

Oct 2003Jan 2004

QC Officer

Cipla LTD

Routine API Analysis


Applications Validated
  • Waters Empower (V1, V2 and V3)
  • Symmex ELN (Electronic Laboratory Note Book)
  • Velquest ELN (Electronic Laboratory Note Book)
  • Labware LIMS (Laboratory Information Management System)
  • Siemens PLC with SCADA for Process Equipments.
  • Allen Bradley PLC with SCADA for Process Equipments
  • Allen Bradley PLC with SCADA for Purified Water Generation and Distribution System.
  • Newtronics Stability Data Monitoring Application.
  • Metrohm Tiamo for Titroprocessor.
Analytical Method Development & Vaidation
  • Method Development – Development of Simultaneous as well as stability indicating method for Dissolution, Assay, impurity and content uniformity using UV-Visible Spectrophotometer and HPLC coupled with HPLC-PDA/UV, HPLC-RI and HPLC-Conductivity detectors for solid oral, creams / ointments and liquid formulations using DoE and Quality By Design approach.
  • Method Validation – Dissolution, Assay, content uniformity and Impurity for solid oral, creams / ointments and liquid formulations.
  • Method Transfer – Dissolution, Assay, impurity and content uniformity for solid oral, creams / ointments and liquid formulations.
Instruments worked On
  • WATERS Alliance HPLC 2487 Dual Wavelength and 2996 Photodiode Array Detector with Millennium and Empower 2 and Empower 3 chromatographic data system.
  • Agilent 1100 HPLC with Chemstation chromatographic data system.
  • SHIMADZU and PERKIN-ELMER UV-Visible Spectrophotometer.
  • DISTEK, VANKEL and ELECTRO-LAB automated online and offline Dissolution Testers.
  • METROHM Karl Fisher Titrator and Auto Titrator.
  • PERKIN ELMER Atomic Absorption Spectrometer.
  • PERKIN ELMER Fourier Transform Infrared Spectrometer.
  • ANATEL PAT 700 TOC analyzer.
  • MALVERN MASTER Sizer 2000 and Master Sizer 3000 Particle Size Distribution Analyaser.
  • BRUKER OPTICS NIR instrument
Computerized System Validation
  • Designed validation protocols for GxP Laboratory Applications and Process Equipments Applications based on the regulatory requirements and internal SOPs.
  • Validated GxP Laboratory Applications and Process Equipments Applications based on the regulatory requirements and internal SOPs using risk based approach.
  • Provided Quality & Compliance CSV guidance, review and approval for projects.
  • Acted as subject matter expert representing CSV during internal, external and regulatory inspections.
  • Facilitated education and training to the organization on compliance procedures and controls; managed timely resolution of audit observations and CAPA.
  • Provided input to stakeholders for continuous improvement.
  • Performed Periodic Review of Computerised Systems based on regulatory requirements.
  • Performed gap assessments against current regulatory requirements.
  • Performed GxP, GAMP and 21 CFR Part 11 assessments for laboratory and process equipment Computerized systems.
  • Actively involved in Empower 3 project implementation on site.
  • Implemented risk based validation approach.
  • Performed computerized systems supplier audits as per EU Eudralex Annex 11 requirements
Quality Management System
  • Change management, CAPA, Deviations, Investigations, Audit management.
  • Conducted Internal GMP Audits, Contract Manufacturers Audits, Active Pharmaceutical Ingredient Manufacturer Audits, Excipients Supplier Audits, Computer Validation Audits Supplier Audits Laboratory Audits. Conducted Good Laboratory Practices (GLP) audits.
  • Imparted GxP Training, including GCPs, GMPs, 21 CFR Part 11, good auditing techniques and facing regulatory audits.
  • Devised and implemented audit management manual for the site.
  • Quality Systems Development, Implementation, and Improvement of strategic partners and external parties.
  • Conducted internal GMP audits, and supplier/vendor audits.
  • Conducted Computer Systems Compliance Audits based on USFDA 21 CFR Part 11 and EU Annex 11 requirements.
  • Active Pharmaceutical Ingredient Manufacturer Audits based on USFDA 21 CFR Part 210 and 211.
  • Conducted Excipients Supplier Audits.
  • Conducted External Laboratory Audits.
  • Developed of Policies and Standard Operating Procedures for auditing, quality management systems.
  • Prepared Quality Improvement Plan for the department.
Quality Risk Management
  • Devised and implemented risk based approach for internal auditing.
  • Devised and implemented risk based assessment checklist for remote / desk top audits for GMP service providers.
  • Prepared and executed risk assessment for GMP service providers.
  • Prepared and executed risk assessment for IT systems based on GAMP 5 guide.
  • Devised and implemented risk based approach for Analytical method validation and transfer.
  • Implemented risk based approach for Equipment Qualification and Computerised System Validation.
  • Devised and executed risk based calibration model for laboratory instruments
Operational Excellence
  • Developed, validated and transferred analytical methods using lean sigma principles i.e. DoE, PDCA, DMAIC process understanding, FMEA, Fishbone diagram etc.
  • Devised and implemented “Poke-Yoke” (mistake proofing) for Analytical and Micro balances.
  • Devised and implemented lean sigma principles i.e. “Kaizen” for analytical methods evaluations as a part of continuous improvement.
  • Coached and mentored QC colleagues on Lean Sigma tools by assessing analytical methods and  method transfers
Data Integrity
  • Identified and escalated Data Integrity issues to senior management in timely manner.
  • Performed Data Integrity Assessments for various laboratory instruments and computerized systems.
  • Designed FMEAs for Data Integrity.
  • Performed Data Integrity gap assessments with respect to recent warning letters and 483s and
  • Implemented processes to fulfill the regulatory requirements
  • Devised process of periodic audit trail review for all computerized systems.
  • Performed Process Flow Mapping in Data Integrity using Lean Sigma principles.
  • Have good understanding of USFDA and EU ALCOA+ terminologies.
Software Proficiency
  • Proficiency in STATISTICA and MINI-TAB Statistical analysis.
  • DX 7 for DoE - Design of Experiments.
  • Track wise Event Tracking System for handling of Event, Deviations, Change control CAPA and Audit Management.
  • Microsoft Word, Excel and Power Point
People Management

Having proven people management skills, with the ability to manage performance and motivate staff on an individual and team level.

Lead team of 5 analytical development scientists at GlaxoSmithKline Pharmaceuticals LTD.

Effectively worked as matrix leader at Janssen Cilag Pharmaceuticals LTD under matrix, virtual and global model.


Dr. Sripad Naik, General Manager.

General Manager. Analytical Sciences at Johnson & Johnson

Dr.Pravin Singare, Professor

Professor at Bhavan's College and Research Guide

Rewards and Recognitions

  • Modified the “Thyroxin Tablets” Indian Pharmacopeia 2010 monograph for Assay HPLC method, this modified method is accepted by Indian Pharmacopeia in 2012 amendment. All drug products manufactured for Indian market are released by this method.
  • GlaxoSmithKline Pharmaceuticals awarded “BRAVO” for Indian Pharmacopeia method amendment of Thyroxin Tablets drug product.
  • GlaxoSmithKline Pharmaceuticals awarded “BRAVO” for quick execution of method validation and transfer with sense of urgency.
  • Johnson & Johnson Pharmaceuticals awarded “Encore Gold” award for devising method equivalency protocol and review with sense of urgency.
  • Johnson & Johnson Pharmaceuticals awarded Encore Platinum award for setting up Quality By Design approach on Analytical Balances.
  • Johnson & Johnson Pharmaceuticals awarded 1-Gold and 1-Silver Encore awards for supporting NDA filings through review and approvals of method validation, transfer and Stability reports approvals with sense of urgency.
  • Johnson & Johnson Pharmaceuticals awarded Gold award for active participation in US-FDA audit in year 2014.
  • Johnson & Johnson Pharmaceuticals awarded Encore Gold for “Adapting Early Change”
  • Developed and validated GREEN method for various drug products using DoE and statistical tools.
  • Selected as Technical review expert to evaluate new source of APIs and Excipients.

Further Study Details

Pursuing PhD in Analytical Method Development and Validation utilizing Quality By Design approach.