Summary
Overview
Work History
Education
Skills
Websites
Latest Education
Accomplishments
Certification
Additional Information
Timeline
AdministrativeAssistant
Nilesh Kambli

Nilesh Kambli

Deputy General Manager, Corporate Quality
Anjuna

Summary

Dynamic and results-driven Senior Pharmaceutical Quality Leader with over 20 years of progressive experience in Quality Control, Quality Assurance, and Corporate Quality functions across leading pharmaceutical organizations. Recognized as a Data Integrity expert and Certified Lead Auditor, with deep expertise in Computerized System Validation (CSV), IT Quality Assurance, and regulatory frameworks including 21 CFR Parts 11 & 211, and EU Annex 11.

Demonstrates a proven track record in regulatory compliance, investigations (OOS, deviations, market complaints, product recalls), and implementation of robust quality systems. Adept at conducting comprehensive audits of external manufacturers, testing laboratories, and CSV service providers, ensuring end-to-end GMP compliance across global supply chains.

A strategic thinker and transformational leader, skilled in leading cross-functional teams through successful regulatory inspections (USFDA, MHRA, EU-GMP, SAPHRA, ANVISA), while driving digital innovation, including automation and AI-based solutions, to enhance operational excellence and data integrity.

Committed to upholding the highest standards of pharmaceutical quality and compliance, while fostering a culture of continuous improvement and proactive risk management.

Overview

21
21
years of professional experience
7
7
years of post-secondary education
1
1
Certification
3
3
Languages

Work History

Deputy General Manager, Corporate Quality

Hetero Labs Limited
08.2024 - Current


  • Lead and manage a high-performing team of Corporate Quality Assurance (CQA) professionals, driving IT compliance, computerized system development, validation, implementation, and comprehensive lifecycle support across all API units of the Hetero Group.
  • Ensure robust compliance with global regulatory frameworks, including 21 CFR Part 11 and EU Annex 11, through meticulous system governance and validation oversight.
  • Conduct in-depth assessments of existing systems and procedures to proactively identify and mitigate potential data integrity risks, reporting findings to senior leadership and implementing risk-based corrective measures through electronic controls or procedural enhancements.
  • Champion the adoption of advanced technologies, including automation and AI-based solutions, to optimize workflows, improve compliance, and enhance overall operational efficiency.
  • Propose, design, and lead the development of innovative digital applications, integrating Artificial Intelligence (AI) to support predictive analytics, investigation management, and compliance monitoring.
  • Successfully manage multiple concurrent projects, consistently delivering results within defined timelines and quality standards, while ensuring adherence to regulatory and business requirements.
  • Foster cross-functional collaboration through strong stakeholder engagement, enabling effective change management and successful system rollouts.
  • Drive data-driven decision-making by implementing advanced data management systems and leveraging data analytics to provide actionable insights for quality and operational improvements.

Associate General Manager, Corporate Quality

Unichem Laboratories Limited
08.2019 - 08.2024
  • Team Management: Managed a Dynamic team of high performing professionals responsible for performing vendor audits, Unichem site audits and managing the site compliance and all time audit readiness focusing on maintaining Data Integrity across the Company.
  • Strategic Quality Leadership & Audit Readiness: Spearheaded company-wide initiatives to ensure audit readiness and regulatory compliance across Unichem’s global manufacturing sites (India, Brazil, South Africa, Ireland). Led a high-performing team focused on vendor audits, internal site audits, and compliance oversight with a strong emphasis on data integrity governance and QMS alignment. Actively guided sites during regulatory inspections and authored comprehensive regulatory responses.
  • Data Integrity & Quality Systems Oversight:
    Established a structured mechanism for the identification, investigation, and remediation of data integrity concerns across the organization. Led root cause analysis, impact assessments, and corrective action planning, ensuring systemic closures routed through QMS. Drove cultural transformation by embedding data integrity principles into routine operations.
  • Regulatory Compliance & Global CAPA Management: Leveraged regulatory inspection outcomes (e.g., USFDA 483s) to develop and implement global CAPAs, ensuring cross-site learning and standardization. Provided expert oversight in investigations related to OOS, deviations, market complaints, product recalls, and led or approved resolution strategies across API and formulation sites.
  • IT Quality Assurance & System Validation (CSV): Accountable for IT compliance, validation, implementation, and lifecycle support of computerized systems across Unichem, in accordance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
    Led corporate implementation and validation of enterprise systems, including:
    Caliber LIMS, QAMS, DMS (QA/QC management)
    Educe DocsExecutive & Dossier Management Systems
    SAP ERP, SAP SuccessFactors LMS, ZingHR HRMS
    Directed qualification activities (IQ/OQ/PQ), risk assessments, SOP development, and user training for all major implementations.
  • Global Quality & Technical Expertise: Provided technical and scientific leadership for the preparation, review, and approval of key quality documents including analytical method validation protocols/reports, change controls, specification revisions, and annual guideline updates.
    Extended expertise to international subsidiaries by supporting the QC operations of Unichem Brazil, South Africa, and Ireland, fostering unified quality standards globally.
  • Vendor & Supplier Quality Management: Qualified auditor for external entities including API, KSM, formulation manufacturers, packaging suppliers, contract labs, and IT service providers. Oversaw vendor qualification, performance review, and periodic evaluation processes to ensure sustained supply chain compliance and quality.

Manager – Quality Control

Sanofi Synthelabo India Pvt. Ltd.
06.2010 - 07.2019


  • Team Leader – Quality Control & Compliance: Led dynamic QC team in planning and allocating analytical activities. Oversaw review, approval, and disposition decisions. Supervised calibration, performance verification, and qualification of instruments and laboratory equipments.
  • Qualified and Sanofi Certified Auditor with extensive experience in auditing suppliers, manufacturers, contract laboratories, and CMOs. Accountable for planning and execution of audit schedules, preparing audit plans, conducting audits, training and qualifying junior auditors, and reviewing audit reports. Ensure timely closure and effectiveness of CAPA responses from audited sites.
  • Regulatory Compliance Expertise: Proven expertise in regulatory compliance with 21 CFR Part 211, 21 CFR Part 11, EU Annex 11, and global data integrity requirements. Well-versed in preparing and reviewing SOPs, stability protocols, stability trends, annual product reviews, and water system reports.
  • Project Management & System Implementation:
    Caliber LIMS, Empower 3, and Newtronics ICDAS:     Served as Project Manager and Technical Lead for implementation across QC and ADL. Led design qualification, risk assessments, IQ/OQ/PQ executions, SOP development, user training, and system go-live for all three platforms. Ensured compliance with GAMP and regulatory expectations throughout the system lifecycle.
  • Method Development, Validation & Transfers: Proficient in analytical method development for solid orals and soft gelatin capsules using HPLC and GC. Led method validations and transfers for raw materials and drug products, including protocol preparation, execution, and reporting.
  • Training & Capability Building: Conducted extensive training programs on regulatory guidelines (GLP, GMP, GDP), analytical techniques, instrumentation, and SOPs. Developed and validated Excel-based calculation sheets for analytical testing.

Executive, Quality Control

Unichem Laboratories Limited
03.2006 - 06.2010


  • Led the implementation, qualification, and training of major laboratory informatics systems including Agilent OpenLAB, CaliberLIMS and Waters Empower, ensuring seamless integration with Quality Control operations and compliance with regulatory standards.
  • Acted as Project Manager and Technical Expert, overseeing full lifecycle deployment of computerized systems for QC data acquisition and management.
  • Played a key role in regulatory inspections and audits conducted by USFDA, MHRA, TGA, ANVISA, WHO, MCC, local FDA, and global clients; directly interacted with auditors and supported successful outcomes.
  • Managed stability studies, including protocol preparation, trend analysis, sample loading/withdrawal, planning, and execution of stability testing.
  • Performed and reviewed analysis of raw materials, packaging materials, in-process, validation, finished product, and stability samples as per cGMP requirements.
  • Executed and reviewed analytical method validations for drug products using HPLC, and ensured instrument calibration, maintenance of HPLC systems, and column management.
  • Maintained and managed working standards, impurity standards, and reference standards, ensuring data accuracy and compliance.
  • Provided IT support for QC computer systems with a focus on data security and integrity, contributing to enhanced electronic record controls.
  • Authored and trained team members on Standard Operating Procedures (SOPs) related to analytical operations and quality system requirements.

Chemist

Panandiker R&D Pvt Ltd
08.2004 - 03.2006


  • Performed synthesis and process development of chemical intermediates, optimizing routes for improved yield, purity, and scalability.
  • Supervised and guided the scale-up of pilot batches at multiple manufacturing facilities, ensuring smooth technology transfer and reproducibility of lab-scale results.
  • Demonstrated expertise in experimental design and execution at both laboratory and pilot plant scale, ensuring process safety, robustness, and cost-effectiveness.
  • Executed purification of crude intermediates to achieve high-quality final products meeting stringent specifications.
  • Provided non routine analytical support to maintain in-process control, monitor critical parameters, and ensure consistent product quality throughout the development lifecycle.

Education

MBA - Project Management

Sikkim Manipal University
04.2016 - 01.2019

Master of Science - Science – Organic Chemistry

Goa University
Goa
04.2002 - 01.2004

Bachelor of Science - Science - Chemistry

St. Xaviers College
Mapusa Goa
04.1999 - 01.2002

Skills

Data Integrity

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Latest Education

  • Master’s in Business Administration (MBA), Project Management, Sikkim Manipal University, 08/01/16, 08/01/19
  • Master’s degree, Science – Organic Chemistry, Goa University, 08/01/02, 08/01/04
  • Bachelor’s degree, Science - Chemistry, St. Xaviers College, 08/01/99, 08/01/02

Accomplishments

Recipient of the "Artificial Intelligence Pioneer Award" at the Pharma Quality Excellence Awards 2025 by the EBM Group, in recognition of developing the innovative Root Cause Analysis using Artificial Intelligence (RCAI) application. This cutting-edge tool transformed the pharmaceutical investigation process by leveraging AI for root cause identification, hypothesis generation, impact assessment, CAPA recommendation, and automated training content creation, significantly enhancing investigation efficiency, consistency, and regulatory compliance.

Certification

 Approved Chemist by Department of Foods and Drugs Administration (Goa FDA), Government of Goa, India, as an Expert in Chemical and Instrumentation, vide certificate No. 66(2637)/MFG/APP/DFDA/06/11227

Additional Information

Invention of Bi-layer tablet formulations of cyclophosphamide and capecitabine and highly fractionated metronomic administration to treat cancer, e.g., breast cancer which is a convenient and stable bi-layer oral tablet formulation of cyclophosphamide and capecitabine. Patent Number: W02015189807A1


Timeline

Deputy General Manager, Corporate Quality

Hetero Labs Limited
08.2024 - Current

Associate General Manager, Corporate Quality

Unichem Laboratories Limited
08.2019 - 08.2024

MBA - Project Management

Sikkim Manipal University
04.2016 - 01.2019

Manager – Quality Control

Sanofi Synthelabo India Pvt. Ltd.
06.2010 - 07.2019

 Approved Chemist by Department of Foods and Drugs Administration (Goa FDA), Government of Goa, India, as an Expert in Chemical and Instrumentation, vide certificate No. 66(2637)/MFG/APP/DFDA/06/11227

11-2009

Executive, Quality Control

Unichem Laboratories Limited
03.2006 - 06.2010

Chemist

Panandiker R&D Pvt Ltd
08.2004 - 03.2006

Master of Science - Science – Organic Chemistry

Goa University
04.2002 - 01.2004

Bachelor of Science - Science - Chemistry

St. Xaviers College
04.1999 - 01.2002

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Nilesh KambliDeputy General Manager, Corporate Quality