NAVEEN BALASUBRAMANIAM
Erode
Summary
Results-driven Pharmaceutical Quality Assurance Professional with 7.6 years of progressive experience across production operations and core QA environments. Demonstrated expertise in managing Quality Management Systems (QMS), executing quality complaint investigations, and driving controlled-document review and approval workflows in strict compliance with global regulatory standards (USFDA, EU GMP, MHRA). Proven track record in conducting detailed root cause analyses, tracking CAPA effectiveness, and managing customer feedback records through successful closure. Adept at utilising advanced electronic document management platforms and maintaining precise data tracking to facilitate timely case resolution and support cross-functional business initiatives. Certified Lean Six Sigma Black Belt and ISO 9001:2015 Lead Auditor focused on ensuring data integrity, documentation accuracy, and total SOP compliance
Overview
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1
Language
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1
Certification
8
8
years of professional experience
Work History
Executive – Quality Assurance
COHANCE LIFESCIENCES LIMITED
2026.10 - Current
- Investigation & Quality Records: Own and lead comprehensive scientific investigations for product complaints, deviations, and OOS/OOT occurrences; ensure the accuracy, quality, and data integrity of all complaint records.
- Initiated and defined Corrective and Preventive Actions (CAPA) based on complaint trends, executed effectiveness checks, and improved quality systems continuously.
- Evaluated and managed triaged product complaint records and customer feedback logs from initial receipt to formal closure, ensuring compliance with SOP requirements and enhancing customer satisfaction.
- Process Validation & Audits: Prepare and execute validation protocols (Process and Cleaning Validation) and support regulatory audit management (USFDA, MHRA, EU GMP) via timely documentation delivery.
- Oversaw supplier/vendor qualification workflows, monitored compliance metrics, and maintained corporate approved vendor list to ensure sustained quality and compliance.
- Controlled-Document Workflows: Manage controlled-document review, drafting, and approval workflows for SOPs and protocols, maintaining strict formatting, usability, consistency, and high-quality standards.
- Data Integrity & Tools: Execute QMS transactions in SAP and electronic document management systems; maintain quality trackers and utilize Microsoft Excel and Word to support cross-functional project updates.
Junior Executive – QMS
HETERO LABS LIMITED
2023.02 - 2024.09
- GMP Operations: Supervised oral solid dosage processing (granulation, compression, coating, encapsulation) to ensure compliance with GMP standards and adherence to product quality metrics.
- Documentation & SOP Adherence: Maintained and reviewed batch manufacturing records (BMR) and logs to uphold strict SOP compliance and ensure accurate documentation.
- Deviation & CAPA Assessment: Identified and recorded shop-floor deviations; collaborated with QA teams on preliminary investigations and supported implementation of assigned CAPA actions.
Officer – Production
INDOCO REMEDIS LIMITED
2022.07 - 2023.01
- Performed routine quality checks and monitored physical parameters during manufacturing to identify and mitigate potential product quality defects.
- Audited operational records for accuracy and completeness to ensure compliance before submission to QA, facilitating timely batch release.
- Managed team of junior officers, providing leadership and guidance for operational efficiency.
- Prepared detailed reports for senior management, outlining operational performance and strategic recommendations.
- Responded to emergency calls for service, providing timely assistance and support to individuals in distress.
Junior Officer – Production QMS
HETERO LABS LIMITED
2018.12 - 2022.06
- Authored, reviewed, and implemented standard operating procedures (SOPs) for production floor, ensuring compliance with updated GMP guidelines and enhancing operational consistency.
- Maintained day-to-day batch documentation, ensuring formatting accuracy, timely step signatures, and zero-defect record keeping, contributing to overall quality assurance across manufacturing shifts.
- Executed initiation, documentation, and impact evaluation of manufacturing change controls, ensuring proper authorisation of all technical and operational modifications prior to implementation.
Education
BACHELOR OF PHARMACY - PHARMACY
TNMGR Medical University
Chennai2018-01
Skills
- Electronic Quality Systems: SAP MasterControl (QMS/DMS/LMS) Caliber QMS/LIMS Electronic Log Management System Ampelotic DMS Corporate Document Management Systems (CDOCS pathways)
- Office Software: Microsoft Excel (data tracking/trending) Microsoft Word (controlled document drafting) Microsoft Office Suite
- Manufacturing Equipment: Granulation (ACG, Tapasya, SAAN) Compression (Sejong, Kilian, Korsch, GEA) Coating (ACG, Neocota, Glatt) Encapsulation (ACG)
- Quality Compliant Management Compliant Investigation Quality Management System (QMS) Change Control Deviation OOS/OOT Vendor/Supplier Management SOP Compliance Customer Feedback Management Complaint Records CAPA Awareness GMP CDOCS Controlled Document Management Microsoft Word Microsoft Excel Quality System
- Deviation management
- Change control
- CAPA management
- Document control
- SAP transactions
- Complaint investigations
- Risk assessment
LANGUAGES KNOWN
Tamil – Native/Fluent | English – Fluent (Professional Proficiency) | Hindi – Fluent | Telugu – Fluent
Certification
- Lean Six Sigma Black Belt
- ISO 9001:2015 Lead Auditor
- Supply Chain and Operation Management
Websites, Portfolios, Profiles
https://www.linkedin.com/in/naveen-balasubramaniam
REGULATORY AUDIT EXPOSURE
USFDA | EU GMP | WHO | Japan PDMA | MHRA | TGA | SFDA
Timeline
Executive – Quality Assurance
COHANCE LIFESCIENCES LIMITED
2026.10 - Current
Junior Executive – QMS
HETERO LABS LIMITED
2023.02 - 2024.09
Officer – Production
INDOCO REMEDIS LIMITED
2022.07 - 2023.01
Junior Officer – Production QMS
HETERO LABS LIMITED
2018.12 - 2022.06
BACHELOR OF PHARMACY - PHARMACY
TNMGR Medical University