Harish Madhav Nayak
Bangalore
Summary
Accomplished Quality Control professional with 27+ years of experience in the pharmaceutical industry, specializing in APIs and Biologicals. Extensive expertise in analytical operations, regulatory compliance, and implementation of global quality standards. Delivering consistent quality outcomes and advancing organizational excellence in pharmaceutical quality domains.
Overview
6
6
years of professional experience
6
6
Certifications
4
4
Languages
Work History
Research Associate, Quality Control
Vittal Mallya Scientific Research Foundation
12.2002 - 01.2005
Officer, Quality Control
Cipla Limited
03.2000 - 12.2002
Officer, Quality Control
Karnataka Agro Chemicals Limited
03.1999 - 02.2000
Education
M.Sc. - Inorganic Chemistry
Karnataka University
Dharwad01-1998
Skills
Comprehensive knowledge in handling Incoming materials, In-process, Finished product, Stability testing, and Validation teams
Accomplishments
- Biocon Biologics - Quality Control
- Proven Quality Control leader with 21+ years of progressive advancement at Biocon, rising from Executive to Director (FEB 2005 to till date)
- Directed and mentored teams of 90 + members, improving overall productivity in batch release by 32% and ensuring consistent adherence to high-quality standards across products and services.
- Led multiple strategic projects focused on COGS reduction, cost optimization, capacity optimization, and testing reduction, delivering annual savings of approx. INR 2 Cr.
- Few recent initiatives such as:
- Reduced testing implementation for incoming materials and water samples
- Harmonisation of specifications across all monographs
- Development of alternate vendors to ensure supply chain resilience
- Implementation of skip-lot testing for incoming materials
- ATR testing and Raman-based identification for RM/KSM testing
- Shelf-life studies for lab reagents and volumetric solutions
- Reduced frequency of retesting for raw and packaging materials
- Deployment of CFR Part 11–compliant proofreader software for pack inserts, cartons, and labels
- Actively contributed to quality system improvements and operational process optimization, driving compliance and efficiency gains
- Led evaluation and implementation of EG/DEG testing to strengthen product safety standards
- Conducted risk assessment for Nitrosamine impurities, ensuring regulatory alignment and proactive risk mitigation
- Implemented dose accuracy instrument (evaluation, procurement, and qualification), enhancing precision and compliance in testing processes
- Harmonized TOC calibration procedures in line with guideline requirements, improving consistency and reliability
- Evaluated and qualified new vendors, materials, and device components to support new projects and strengthen supply chain flexibility
- Advanced data analysis for deviation investigations (Trend analysis, Data segmentation, Comparative studies etc), root cause analysis (Fish bone, 5 Why, FMEA), and Process improvement.
- Led project planning and execution during design and commissioning phases of lab infrastructure
- Identified the procedural gaps, addressing the gaps and effective implementations of respective SPECs/Testing procedures SOP’s accordance with global SOP’s and guidelines
- Part of the core team during the implementation of ERP, SAP, LIMS, E-SPEC ODS, DMS etc
- Spearheaded the implementation of digital systems to strengthen data integrity and data security frameworks
Certification
High Potential Leadership Development Program for Indian Institute of Management, Bengaluru
CAREER TIMELINE
Joined Biocon as Executive in 2005, got promoted as Senior Executive (2008), Deputy Manager, Associate manager, Manager (2015), Senior manager (2017) and as Director (2021)
Timeline
Research Associate, Quality Control
Vittal Mallya Scientific Research Foundation
12.2002 - 01.2005
Officer, Quality Control
Cipla Limited
03.2000 - 12.2002
Officer, Quality Control
Karnataka Agro Chemicals Limited
03.1999 - 02.2000
M.Sc. - Inorganic Chemistry
Karnataka University