Narayan Kumar

Experienced Professional with over 25 years in biological and API product manufacturing, with a strong focus on Manufacturing Compliance and QMS. Proven expertise in overseeing and enhancing Quality Systems to ensure site-wide compliance with cGMP and regulatory expectations. Skilled in managing and reviewing Deviations, Change Controls, CAPAs, OOS, and Failure Investigations to drive timely and effective resolution.

Demonstrated ability to lead cross-functional initiatives for continual improvement and ensure consistent product quality. Successfully supported multiple regulatory inspections (USFDA, PMDA, EMA, CDSCO) with positive outcomes, ensuring sustained compliance and readiness.

Compliance Lead – Biologics (MAbs and Insulin) at Biocon Biologics (2022-01 – Present)

• Review of procedures and quality systems and harmonizing the best practices as per compliance and regulation requirements across sites.
• Evaluation and ascertaining the training curriculum for production personnel.
• Investigation of deviation, OOS, OOL, OOT during batch failure and Environmental monitoring excursions.
• CAPA evaluation, CAPA decision and implementation.
• Process validation, cleaning validation – Assessment and review of protocol and reports.
• Training of personnel at shop floor on QMS and cGMP.
• Change management, Handling of Change control and implementation of appropriate changes.
• Risk Assessments to support decision-making on quality events, changes, facility fitness and continuous improvement initiatives.
• Support technology transfer and scale-up at manufacturing sites followed by validation and commercialization.
• Audit preparedness, Audit response preparations, audit CAPA decisions and CAPA implementation.
• As an internal auditor audited other facilities for QMS compliance and cGMP.
• Actively participate in Management Review Meetings, providing insights on KPIs, risks, and compliance performance.

QMS Lead - Insulin DS at Biocon Biologics (2013-01 – 2022-12)

• Drive Qualification and review qualification reports.
• Change management, Risk assessment pertaining to changes in process, equipment and facility.
• Review of batch manufacturing records, SOPs and protocols
• Investigation of deviation, OOS, OOT and batch failure.
• Audit response, CAPA and compliance
• Planning and execution of Process validation and cleaning validation.
• Annual performance quality review and Annual facility review
• Support for DMF and dossier update and addressing customer query.
• Drive inhouse projects and fulfilling all QMS requisites for equipment and process changes.
• Establishing data governance requirements, documentation and data control

Plant In-charge – Insulin DS operations at Biocon Ltd (2006-01 – 2013-12)

• Batch plan and organizing the required resources for plant, process and operations.
• Training of personnel at shop floor on operations, safety and cGMP.
• Capex and Budgeting for Plant and process requirements.
• Review and approval of master batch documents, risk assessment and validation protocols
• Facility fit assessment during process change & new product startup, Hazop report preparation
• Product stabilization, trouble shooting, training, CAPA decision and implementation, Internal audit

Shift In-charge- Enzymes and Statins production plant at Biocon India Ltd (1999-01 – 2006-12)

• Monitoring & control of manufacturing process, cGMP, safety and execute operations.
• Training the production team on process and operations.
• Achieved production targets and met the deliverables.
• Maintaining cGMP in shop floor and safety compliance in all operations
• Reporting deviation and participate in investigation and root cause analysis.

B.Sc in Microbiology – University of Madras

PG Diploma in Industrial Microbiology – Loyola college, Chennai

Diploma in Industrial Safety – Annamalai University

MBA – Madurai Kamaraj University