KARTHIK THANGARAJ
Assistant Manager QA/QC
Erode
Summary
Assistant Manager – QA/QC leading ISO 13485:2016, ISO 9001, and ISO 14001 compliance across QMS, internal audits, CAPA, and batch-release decisions in SAP, reviewing 21+ batches per week and closing 4–8 internal audit observations and non-conformities per month. Drives qualification and validation, completing 50 IQ, OQ, and PQ validation packages per quarter, for RM, PM, IP, and FG controls, including IQ, OQ, and PQ, while tightening documentation, traceability, and data integrity. Strengthens plant-wide quality performance through complaint investigations, root-cause analysis, GMP/GDP training, and cross-functional problem solving, including reducing oversized/unwanted polybags used in packaging to achieve cost savings of ₹3 Lakh and minimize material wastage.
Overview
2
2
Languages
2
2
Certifications
8
8
years of professional experience
Work History
Assistant Manager – QA/QC
Dynamic Techno Medicals Pvt Ltd
11.2024 - Current
- Drive QA/QC operations and QMS compliance in line with ISO 13485:2016, ISO 9001 and ISO 14001 standards.
- Lead internal audits, identify gaps, and ensure timely closure of audit observations and non-conformities.
- Controlled and maintained QMS documentation, SOPs, work instructions, specifications, and quality records to ensure compliance and operational consistency.
- Develop RM, PM, IP and FG Quality Plans, and optimize SOPs and testing procedures for consistent quality control.
- Plan and execute equipment/machine qualification (IQ, OQ, PQ) with complete validation documentation.
- Review batch records and authorize batch release in SAP based on quality and compliance requirements.
- Lead customer complaint investigation, defect analysis, root cause identification and resolution, driving RCA and CAPA using structured problem-solving tools.
- Analyzed monthly product-wise rejection trends and monitored quality KPIs, deviations, and CAPA effectiveness to identify areas for targeted defect reduction.
- Support customer, certification, internal and regulatory audits and ensure audit readiness.
- Manage deviations, non-conformities, investigations, CAPA and change-related quality activities, maintaining data integrity and traceability.
- Promoted Right-First-Time (RFT) principles and a continuous improvement culture across the plant, fostering accountability and quality awareness.
Senior Production Executive
Affigenix Biosolutions Pvt Ltd
12.2022 - 11.2024
- Lead production readiness activities for new product launches, including process validation, equipment qualification, and training of production personnel.
- Develop and implement production plans to meet demand forecasts while optimizing resource utilization. Coordinate with various departments to ensure timely execution of production schedules.
- Identified areas for process optimization and led initiatives to streamline production processes, reducing waste and enhancing productivity.
- Oversaw inventory levels of raw materials, work-in-progress, and finished goods while implementing control measures to optimize turnover and minimize stockouts.
- Oversee inventory levels of raw materials, work-in-progress, and finished goods. Implement inventory control measures to optimize inventory turnover and minimize stockouts.
- Liaised with cross-functional teams, including R&D, quality assurance, supply chain, and sales, to align production activities with organizational goals.
- Liaise with cross-functional teams, including R&D, quality assurance, supply chain, and sales, to ensure alignment of production activities with organizational goals and objectives.
Quality Control Executive
JEEV Diagnostics Pvt Ltd
09.2021 - 11.2022
- Perform QC analysis of clinical chemistry reagent, Viral Transport Medium, RNA extraction kits and RT PCR kits in fully automatic and semi-automatic IVD analyzers.
- Perform internal audit periodically and approve the release of bulk batches.
- Executed bulk manufacturing of clinical chemistry, hematology, and molecular biology IVD reagents, ensuring compliance with quality standards.
- Corporate accounting to verify adherence to quality standards as per ISO 13485:2016 standards.
- Developed quality manual, MSP, and site master file in accordance with ISO 13485:2016 standards to enhance regulatory compliance.
- To execute the accelerated, in use, shipping, accuracy precession, studies for the routine and new clinical chemistry and Hematology IVD products.
- Prepare the DMF, ECP, RMR, validation study reports, label formats to obtain Manufacturing license for IVD reagents from CDSCO,MDR 2017, India.
- Analyzed market complaints and implemented RCA and CAPA processes to address quality issues and improve product reliability.
- Preparation of SOPs and formats.
Project Fellow
University of Madras
08.2018 - 04.2021
- Executed project on elucidating role of AMPK and related kinases in tumorigenesis and therapeutic targeting; investigated influence of aqueous extract Scoparia dulcis Linn on neutrophil responses and implications in inflammatory disease therapeutics.
- Maintained human lung (A549, NCIH460, L132) and breast cancer cell lines (MCF7, MDA MB231, T47D) to assess cytotoxicity of phytochemicals.
- Performing knockout studies by using CRISPR Cas9 gene editing tool.
- Analyze the Cell cycle and apoptotic mechanisms by Flow cytometry technique.
- Analyzed cell cycle and apoptotic mechanisms using flow cytometry technique.
Education
Ph.D. (Part-Time) - Biomedical Sciences
Bharathidasan University
Trichy, India11-2027
Masters - Life Sciences – Biotechnology
Bharathidasan University
Trichy, India04-2018
Higher Secondary School -
Rasama Higher Secondary School
Karur, India03-2013
Skills
Knowledge of quality systems (ISO 13485:2016, ISO 9001, ISO 14001, MDR 2017) and documentation
Working knowledge of SAP QM (Quality Management) module
Internal audits
CAPA
Regulatory audit support
Bulk manufacturing of IVD reagents
Quality control testing of IVD reagents
Equipment qualification
Batch release
Root cause analysis
Change control
Validation protocol authoring
Regulatory inspection readiness
Customer complaint trend analysis
Certification
Certificate in Clinical Research from Institute of Clinical Research, India
Declaration
I hereby declare that all the above information are correct to the best of my knowledge and belief.
Publications
- Thangaraj K, Ponnusamy L, Natarajan SR, Manoharan R. MELK/MPK38 in cancer: from mechanistic aspects to therapeutic strategies. Drug Discov Today. 2020 IF-7.321
- Ponnusamy L, Natarajan SR, Thangaraj K, Manoharan R. Therapeutic aspects of AMPK in breast cancer: Progress, challenges, and future directions. Biochim Biophys Acta Rev Cancer.2020. IF-7.365.
Internships
- Indian Academy of Sciences-INSA-NASI Summer Research Fellow - May -July 2016
- Indian Academy of Sciences-INSA-NASI Summer Research Fellow - May -July 2015
Timeline
Assistant Manager – QA/QC
Dynamic Techno Medicals Pvt Ltd
11.2024 - Current
Senior Production Executive
Affigenix Biosolutions Pvt Ltd
12.2022 - 11.2024
Quality Control Executive
JEEV Diagnostics Pvt Ltd
09.2021 - 11.2022
Project Fellow
University of Madras
08.2018 - 04.2021
Ph.D. (Part-Time) - Biomedical Sciences
Bharathidasan University
Masters - Life Sciences – Biotechnology
Bharathidasan University
Higher Secondary School -
Rasama Higher Secondary School