Balamurugan M

Quality Assurance & Quality Control professional with 17+ years of experience in medical devices, medical device/pharma packaging, and GMP-regulated manufacturing. Strong expertise in ISO 13485:2016, ISO 15378:2017, FSC, CE compliance, cleanroom controls, validation, audits, CAPA, change control, deviations, and complaint handling. Proven leadership experience as Management Representative (MR) and department head across QA, QC, and Production functions.

Deputy Manager – Quality Assurance at Amcor Flexibles India Pvt. Ltd. (2024-10 – Present)

Medical device & pharma primary/secondary packaging manufacturing

Assistant Manager – Quality at Amcor Flexibles India Pvt. Ltd. (2023-09 – 2024-09)

Medical device & pharma primary/secondary packaging manufacturing. Duration – Sep 2023 - Present

• Appointed as Management Representative for ISO 13485:2016, ISO 15378:2017 and FSC ensuring effective implementation and maintenance of the Quality Management System (QMS).
• Ensured compliance of the QMS with ISO standards and regulatory requirements across all dpts.
• Managed control of document and record in line with QMS and GMP requirements.
• Reviewed and approved incoming, in-process, and finished product test reports, including batch release control.
• Handled customer complaints, led investigations, and implemented CAPA to ensure timely resolution and continuous improvement.
• Planned and conducted internal audits and Management Review Meetings (MRM) to evaluate QMS performance.
• Conducted weekly complaint review meetings and monthly change control meetings.
• Coordinated process validation, test method validation, and external lab/service activities.
• Reviewed cleanroom validation reports and ensured compliance to requirements.
• Managed instrument calibration and coordination with external laboratories/service providers for testing and compliance activities.
• Coordinated and supported customer audits and regulatory inspections, including response to regulatory advisories and adverse events.
• Maintained key QMS documentation including CAPA, deviation, change control, risk management, and audit records, while ensuring cross-functional compliance with QMS/GMP requirements.
• Team size: 7 | Reporting: Plant Operations Head & GM Quality India

Manager – QA & QC at Innvol Medical India Ltd (2022-09 – 2023-08)

Medical device – Blood bag manufacturing

Manager – QC at Innvol Medical India Ltd (2021-04 – 2022-08)

Medical device – Blood bag manufacturing

Manager – Special Project / Assistant to WTD at Innvol Medical India Ltd (2020-06 – 2021-03)

Medical device – Blood bag manufacturing

Head – Production at Innvol Medical India Ltd (2017-07 – 2020-05)

Medical device – Blood bag manufacturing

Head – QC at Innvol Medical India Ltd (2015-03 – 2017-06)

Medical device – Blood bag manufacturing

QC Microbiologist at Innvol Medical India Ltd (2012-10 – 2015-02)

Medical device – Blood bag manufacturing. Duration – Oct 2012 – Aug 2023 (10 Years 11 months)

• Managed sampling, testing, and reporting of raw materials, packing materials, in-process, finished goods, and water samples.
• Handled OOS/OOT investigations, trending, and periodic quality review.
• Coordinated instrument calibration, qualification, and laboratory documentation.
• Conducted and reviewed microbiology & chemical method validations.
• Prepared and reviewed SOPs, work instructions, formats, raw data sheets, logbooks.
• Maintained ISO 13485 & CE compliance, internal audit schedules, and audit execution.
• Coordinated process validation, cleanroom validation, and sterilization validation.
• Managed CAPA, deviations, change control, complaint handling, and document control.
• Coordinated GMP and quality training for teams and cross-functional departments.
• Team size: 6 (QA/QC) and 18 (Production) | Reporting: Whole-time Director

QC Microbiologist at S K Biotech (2011-09 – 2012-09)

Ayurvedic products manufacturing

• Performed microbial analysis of raw materials to final product.
• Conducted environmental monitoring, microbial limit tests, and plant hygiene control.
• Maintained GMP documentation, SOPs, and log sheets.
• Supported r&d and new product development.

QC Microbiologist at Sologuard medical devices pvt Ltd (2008-05 – 2011-09)

Disposable syringe manufacturing

• Performed sterility testing, endotoxin testing, and microbial limit testing.
• Conducted environmental monitoring, package integrity checks, and in-process controls.
• Managed calibration and upkeep of microbiology lab instruments.
• Prepared SOPs and supported ISO documentation.

M.Sc. in Microbiology – Jamal Mohamed College (2008)

B.Sc. in Microbiology – Sree Amman Arts & Science College (2005)

PGDCA in Computer Applications – IFC College & Computer Educational Trust (2006)