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Aswin sridharan

@aswinsridharan

CSV and Quality professional at Biocon Biologics who digitized validation workflows and cut document approval cycles by 45%.

India

Message

At Biocon Biologics, I lead validation lifecycle work and provide QA oversight for commissioning and qualification of laboratory equipment and computerized systems. I’ve supported the shift to Computer Software Assurance, reducing documentation and screen-capture volume by 50%.

At HCL Technologies, I managed laboratory information system governance and medical laboratory compliance. I also led validation of a centralized Waters Empower chromatography data system, supporting instrument integration, access controls, audit trails, and electronic records.

Experience

Work history, roles, and key accomplishments

Current

Deputy Manager – Technical Operations

Current

Biocon Biologics

Jan 2022 - Present (4 years 9 months)

Provides QA oversight for commissioning and qualification of laboratory equipment and computerized systems, and leads validation lifecycle documentation. Directed CSV projects, CSA migration, risk management, and data integrity governance.

CSV CSA GAMP 5 Best Practices FDA 21 CFR Part 11 ICH Q9 (Quality Management)FMEA ALCOA+ Standards Veeva Vault Jira SharePoint SDLC IQ OQ PQ Validation Risk Assessment Data Integrity

Technical Lead – Laboratory Management

HCL Technologies

Apr 2015 - Jan 2022 (6 years 9 months)

Maintained medical laboratory operations in compliance with ISO 13485, 21 CFR 820, and EU MDR. Managed LIS deployment, authored SOPs, and led a team of laboratory technicians.

ISO 13485 21 CFR 820 EU MDR LIS IQ OQ PQ Validation SOP Development Microsoft Project Team Leadership Regulatory Compliance

Assistant Manager – Quality Assurance

CVR Labs Pvt Ltd

Sep 2012 - Apr 2015 (2 years 7 months)

Executed laboratory quality programs in compliance with ISO/IEC 17025, ISO 9001:2008, and ISO 18001:2007. Conducted internal audits, managed calibration schedules, and supported QC/QA activities.

ISO IEC 17025 ISO 9001 OHSAS 18001 Internal Audit Calibration QC QA Statistical Software Documentation

Assistant Manager – Quality Assurance

Sargam Labs Pvt Ltd

Jul 2012 - Sep 2012 (2 months)

Responsible for implementation of the quality system as required by regulatory agencies and ISO/IEC 17025.

ISO IEC 17025 QMS Implementation Regulatory Compliance

Executive – Quality Assurance

SGS India Pvt Ltd

Aug 2008 - Jun 2012 (3 years 10 months)

Updated laboratory quality system documentation in compliance with ISO/IEC 17025:2005. Conducted internal quality control checks, monitored SPC charts, and performed internal audits.

ISO IEC 17025 Internal Audit SPC CAPA Calibration HSE Compliance Customer Complaint Management