Kamalanathan Ganapathi
Quality And Compliance Specialist
Chennai
Summary
Dynamic Process Manager with extensive experience at Novartis Limited, specializing in quality assurance and process validation. Proven track record in enhancing operational excellence and compliance through effective project planning and team collaboration. Skilled in implementing LIMS and eQMS, while fostering a culture of continuous improvement and accountability among team members.
Overview
20
20
years of professional experience
Work History
Process Manager
Arcolab Limited
12.2025 - Current
- End-to-end validation planning and project execution for IT and laboratory systems in the GxP area.
- Authoring and reviewing computerized systems validation deliverables, like PVP, URS, FS, CS, DS, IRA, FRA, IQ, OQ, PQ, TRM, and PVR, using tools like HP ALM, JIRA, and QTEST (Waterfall and Agile methods).
- Responsible for ensuring the compliance of Quality Management events, such as Change Management, CAPA, Deviations, QRM, and Risk Assessment.
- Responsible for ensuring the compliance of Quality Assurance activities, such as process validation, equipment validation, and system validation.
- As a project manager and validation lead, I am implementing the Enterprise Applications, such as eQMS, LIMS, and SAP systems.
- Increased overall productivity by providing training and support for team members in best practices and techniques.
- Empowered team members to take ownership of their roles by providing clear expectations, guidance, and support in achieving personal performance objectives.
- Collaborated with cross-functional teams to identify areas of improvement, leading to increased efficiency across departments.
- Streamlined process workflows by identifying inefficiencies and implementing targeted improvements.
- Evaluated and implemented new technologies or process enhancements for continuous improvement opportunities, staying current with industry trends and advancements.
LEAD- CSV and IT Compliance
QX INDIA TECHNOLOGY SERVICES (NOVARTIS GTX, US), CHENNAI
06.2021 - 11.2025
- End-to-end validation planning and project execution for IT and laboratory systems in the GxP area, as per the Novartis process.
- Responsible for ensuring the compliance of process validation, equipment validation, and system validation.
- Authoring and reviewing computerized systems validation deliverables, like PVP, URS, FS, CS, DS, IRA, FRA, IQ, OQ, PQ, TRM, and PVR, using tools like HP ALM, JIRA, and QTEST (Waterfall and Agile methods).
- Subject Matter Expert for the review of risk assessments, change management, defect management, and CAPA.
- Perform periodic review, disaster recovery testing, and data migration activities.
- Responsible for ensuring the compliance of the ERP system, LIMS, ACE, and other applications.
- Self-motivated, with a strong sense of personal responsibility.
- Passionate about learning and committed to continual improvement.
- Excellent communication skills, both verbal and written.
- Proven ability to learn quickly and adapt to new situations.
- Skilled at working independently and collaboratively in a team environment.
Manager – Quality Assurance
CAPLIN STERILES LIMITED, CHENNAI
03.2018 - 06.2021
- Responsible for the instruments and equipment qualification, such as IQ, OQ, and PQ, and computer system validation (CSV) for the GMP systems (both manufacturing and quality control).
- Preparation and review of the Standard Operating Procedures.
- Authoring and reviewing of computerized systems validation, PLCs, and SCADA system validation deliverables, such as URS, FS, CS, DS, PVP, IRA, FRA, IQ, OQ, PQ, TRM, and PVR.
- Ensuring the compliance of quality systems and data integrity compliance.
- Responsible for the Internal Auditor in cross-functional teams, and an active member for regulatory audits.
- Onboarded new employees with training and new-hire documentation. Defined clear targets and objectives, and communicated them to other team members.
- Trained personnel in equipment maintenance, and enforced participation in exercises focused on developing key skills. Ensured compliance with industry regulations and legal requirements by implementing comprehensive policies and training programs for staff members.
- Managed and motivated employees to be productive and engaged in work.
- Accomplished multiple tasks within established timeframes.
- Maximized performance by monitoring daily activities and mentoring team members.
Deputy Manager – QC & Compliance
STRIDES SHASUN LIMITED, BENGALURU
11.2011 - 02.2018
- As a Team Lead in Quality Control compliance, ensure the compliance of all the application compliance.
- Responsible for the instruments and equipment qualification, such as IQ, OQ, and PQ, and computer system validation (CSV) for the GMP systems (both manufacturing and quality control).
- Responsible for the administration of all laboratory software, such as Chrome Leon 6.8 and 7.2 versions, Lab Solution, Empower, GC Solution, etc.
- Responsible for the investigation of analytical errors, out of specification.
- Preparation and review of the Standard Operating Procedures.
- Periodic review of software audit trail verification.
- Training coordinator for the Quality Control department in Compliance Wire.
- Responsible for ensuring compliance for all the IT applications, like Chrome Leon, Waters, Lab Solutions, LIMS, ILAB, SAP, TrackWise system, Compliance Wire, BMS system, Access Management Systems, all the laboratory applications, PLCs, and SCADA systems.
- Acted as an Internal Auditor, auditing the IT applications periodically. An active member in the Regulatory Audits across the locations.
- Supported overseas teams through online communication, as well as during visits to Singapore and Africa.
- Collaborated with cross-functional teams to drive business growth and achieve corporate objectives.
Executive – Quality Control
SOFTGEL HEALTHCARE PVT. LTD., CHENNAI
08.2010 - 10.2011
- Review of all analytical data, such as raw materials, finished products, stability reports, calibration reports, and method verification reports.
- Preparation of SOPs, Specifications for Finished Products, Raw Materials, and Packing Materials.
- Investigated customer complaints, and performed corrective actions to resolve quality issues.
- Monitored staff organization, and suggested improvements to daily functionality.
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Established long-term client relationships through consistent delivery of high-quality products and services.
- Enhanced customer satisfaction by streamlining communication channels and improving response times.
Junior Executive – Quality
APEX LABORATORIES LTD., CHENNAI
11.2005 - 12.2010
- Analysis of intermediate and finished products in tablets, oral liquids, hard gelatin, and soft gelatin capsules.
- Investigated customer complaints, and performed corrective actions to resolve quality issues.
- Monitored staff organization, and suggested improvements to daily functionality.
- Preparation of SOPs, Specifications for Finished Products, Raw Materials, and Packing Materials.
- Collaborated with cross-functional teams to develop and implement process and system improvement
- Optimized operational efficiency by redesigning processes, systems, and workspaces for increased productivity.
Education
Master of Science - Biochemistry
Bharathidasan University
Kumbakonam, India 04.2001 -
Skills
Quality Assurance/ Quality Control
Process Validation
Computer system validation
Laboratory Information Management System (LIMS)
ERP (SAP & QAD)
eQMS (Trackwise, Veeva Vault, Service Now)
QMS (Change Control, QMR, CAPA, Deviation, RCA)
Process automation
Operational excellence
Teamwork and collaboration
Project planning
Timeline
Process Manager
Arcolab Limited
12.2025 - Current
LEAD- CSV and IT Compliance
QX INDIA TECHNOLOGY SERVICES (NOVARTIS GTX, US), CHENNAI
06.2021 - 11.2025
Manager – Quality Assurance
CAPLIN STERILES LIMITED, CHENNAI
03.2018 - 06.2021
Deputy Manager – QC & Compliance
STRIDES SHASUN LIMITED, BENGALURU
11.2011 - 02.2018
Executive – Quality Control
SOFTGEL HEALTHCARE PVT. LTD., CHENNAI
08.2010 - 10.2011
Junior Executive – Quality
APEX LABORATORIES LTD., CHENNAI
11.2005 - 12.2010
Master of Science - Biochemistry
Bharathidasan University
04.2001 -